Stryker

Neuroform EZ® Stent System

Açıklamalar


Neuroform EZ® Stent System


Neuroform EZ® Stent System is manufactured by Boston Scientific for Stryker Neurovascular.

Flexible Design – Enhanced Delivery
Introducing the industry leading self-expandable and conformable stent design with a simplified delivery system. By reducing stent delivery to three steps - Access, Advance, Deploy - enhanced control meets efficiency.

90644755.AB



Features & Benefits



Flexible Stent Design and Conformable Design
Segmental™ Expansion designed to promote stent anchoring and stent stability
Hybrid Cell Architecture designed to provide flexibility and conformability in tortuous anatomy
Three-Connector Design engineered for consistent conformability, flexibility and accessibility
Cell openings designed to provide aneurysm access across size offerings
Nitinol self-expanding stent helps provide balance of radial force and gentle deployment

Simplified Delivery System, Accurate Placement

Three Steps to Deploy


ACCESS


ADVANCE


DEPLOY

1. PRE-SHAPED DISTAL TIP
Similar tip softness as Transend® 300 Floppy Guidewire

2. RADIOPAQUE POSITIONING BUMPERS
Assists with system visualization during placement


3. WHITE FLUORO SAVER MARKER
Designed to reduce fluoroscopy time

4. INTRODUCER SHEATH
Purple tip is designed for visibility when transferring stent and reloading stent system if desired

31,000 Cases and Counting
Neuroform Microdelivery Stent System Timeline

1 Cumulative worldwide cases from 2002 to end of that year.

* Humanitarian Device. The Neuroform® Microdelivery Stent System is authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ? 2mm and ? 4.5mm that are not amenable to treatment with surgical clipping. Wide-neck aneurysms are defined as having a neck ? 4mm or a dome-to-neck ratio < 2. The effectiveness of this device for this use has not been demonstrated. IRB Approval Required. Please contact your local sales representative for details about ordering this product.

Kullanım Talimatları

INDICATIONS FOR USE

Humanitarian Device. Authorized by Federal law for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ? 2mm and ? 4.5mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck ? 4mm or a dome-to-neck ratio
2. The effectiveness of this device for this use has not been demonstrated.

CONTRAINDICATIONS
Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.

ADVERSE EVENTS
Potential complications include, but are not limited to: aneurysm perforation/rupture, coil herniation through stent into parent vessel, death, embolus, hemorrhage, in-stent stenosis, infection, ischemia, neurological/intracranial sequelae, pseudoaneurysm, stent migration/embolization, stent misplacement, stent thrombosis, stroke, transient ischemic attack, vasospasm, vessel occlusion or closure, vessel thrombosis, vessel perforation/rupture, dissection, trauma or damage, other procedure complications including but not limited to anesthetic and contrast media risks, hypotension, hypertension, access site complications. Refer to the appropriate embolic coil DFU for other complications that may occur due to coil embolization. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

WARNINGS

• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific Representative.

• For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

• This device should only be used by physicians who have received appropriate training in interventional neuroradiology or interventional radiology and preclinical training on the use of this device as established by Boston Scientific.

• Select a stent size (length and diameter) to maintain a minimum of 4 mm on each side of the aneurysm neck along the parent vessel. An incorrectly sized stent may result in damage to the vessel or stent migration. Therefore, the stent is not designed to treat an aneurysm with a neck greater than 22 mm in length.

• If excessive resistance is encountered during the use of the Neuroform EZ Stent System or any of its components at any time during the procedure, discontinue use of the stent system. Continuing to move the stent system against resistance may result in damage to the vessel or a system component.

• Purge the system carefully to avoid the accidental introduction of air into the stent system.

• Confirm there are no air bubbles trapped anywhere in the stent system.

CAUTIONS / PRECAUTIONS

• Federal Law (USA) restricts this device to sale by or on the order of a physician.

• Resale of this device is prohibited by US law.

• The Neuroform EZ Stent System is provided STERILE for single use only. Store in a cool, dry place.

• Use Neuroform EZ Stent System prior to the "Use By" date printed on the package.

• Carefully inspect the sterile package and Neuroform EZ Stent System prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components.

• For MRI Information, please refer to the "MRI Information" section of the Directions for Use.

• The Neuroform EZ Stent System should not be used for recapturing the stent.

• Exercise caution when crossing the deployed stent with adjunct devices.

• After deployment, the stent may foreshorten up to 1.8% in 2.5 mm stents and up to 5.4% in 4.5 mm stents.

• The safety of the Neuroform EZ Stent System in patients below the age of 18 has not been established.

*Humanitarian Device. The Neuroform®Microdelivery Stent System is authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ? 2mm and ? 4.5mm that are not amenable to treatment with surgical clipping. Wide-neck aneurysms are defined as having a neck ? 4mm or a dome-to-neck ratio < 2. The effectiveness of this device for this use has not been demonstrated. IRB Review Required. Please contact your local sales representative for details about ordering this product.

GDC® 360° Detachable Coils

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GDC® 360° Detachable Coils


GDC® 360° Detachable Coils are manufactured by Boston Scientific for Stryker Neurovascular.

Complex. Versatile. Proven.
Let your Strategy Take Shape.

90586663.AC



Features & Benefits



Complex

 

Versatile
Delivering conformability and stability in a single product family.

Choice of Softness
Three grades of softness offer progressive coil compliance throughout the procedure.

Advanced Conformability
Supports a wide range of aneurysm morphologies, from spherical to multi-lobed.


*Glass model test results may not necessarily be indicative of clinical performance

Proven
The #1 Choice for Complex Coils — With Documented Clinical Results
Since 2004, over 200,000 GDC® 360° Detachable Coils have been implanted in patients worldwide
Studies suggest improved angiographic outcomes with GDC 360° Coils when compared to alternative complex and helical shapes (1,2)

(1) Perl J, et al. Presentation at ASITN Practicum in Chicago, IL - June 15-16, 2007.
(2) Taschner C, et al. Neuroradiology, January 2009, 51:45-52.

* Each aneurysm was filled with one 10 mm x 30 cm GDC-10 360° Standard SR Detachable Coil. Comparative clinical study results on file at Stryker Corporation. Data available upon request. Bench test data. Bench test results may not necessarily be indicative of clinical performance. All photographs taken by and on file at Stryker Corporation.

Kullanım Talimatı

INDICATIONS FOR USE
GDC 360° Detachable Coils are intended for embolization of those intracranial aneurysms that – because of their morphology, their location, or the patient's general medical condition – are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable. GDC 360° Detachable Coils are also intended for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. GDC 360° Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature. This device should only be used by physicians who have received appropriate training in interventional neuroradiology or interventional radiology and preclinical training on the use of this device as established by Boston Scientific.

CONTRAINDICATIONS
None known.

POTENTIAL ADVERSE EVENTS
Potential complications include, but are not limited to: post embolization syndrome, hematoma, hemorrhage, vessel perforation, emboli (foreign, thromboembolic), ischemia, vasospasm, revascularization, inadequate occlusion, and neurological deficits including stroke and possibly death. Please be aware that potential adverse events may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

WARNINGS

• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.

• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

• Do not use if sterile packaging has been breached or damaged. Do not use if past "use by" date on package.

• Damaged delivery wires may cause vessel injury or unpredictable distal tip response during coil deployment.

• Utilization of damaged coils may affect coil delivery to, and stability inside, the vessel or aneurysm, possibly resulting in coil migration and/or stretching.

• Do not rotate delivery wire during or after delivery of the coil into the aneurysm.Rotating the GDC 360° delivery wire may result in stretched coil or premature detachment of the coil from the delivery wire which could result in coil migration.

• Verify repeatedly that the distal shaft of the catheter is not under stress before detaching the GDC 360° Detachable Coil. Axial compression or tension forces could be stored in the 2-tip infusion catheter causing the tip to move during coil delivery. Catheter tip movement could cause the aneurysm or vessel to rupture.

• Advancing the delivery wire beyond the catheter tip once the coil has been detached involves risk of aneurysm or vessel perforation.

• If undesirable movement of the coil can be seen under fluoroscopy following coil placement and prior to detachment, remove the coil and replace with another more appropriately sized coil. Movement of the coil may indicate the coil could migrate once it is detached. Angiographic controls should also be performed prior to detachment to ensure that the coil mass is not protruding into the parent vessel.

• Increased detachment times may occur when:

• Delivery wire/catheter markers are not properly aligned.

• There is improper setup of continuous flush.

• Other embolic agents are present.

• Tungsten and/or other non-platinum coils are already present within the aneurysm. It is therefore recommended that GDC 360° Detachable Coils not be used in the presence of non-platinum coils.

• Boston Scientific Detachable Coil Connecting Cables (M00345110240) has been resterilized. Boston Scientific Detachable Coil Connecting Cables are supplied for one use only and should be discarded after each procedure.

• Boston Scientific Detachable Coil Connecting Cables are intended for one use only. Do not resterilize and/or reuse. Resterilization could corrode the Boston Scientific Detachable Coil Connecting Cables, resulting in increased detachment times.

• Dispose of used Boston Scientific Detachable Coil Connecting Cables and coil devices in accordance with hospital, administrative and/or local government policy.

• If coil repositioning is necessary, take special care to retract coil under fluoroscopy in a one-to-one motion with the delivery wire. If the coil does not move with a one-to-one motion, or repositioning is difficult, the coil has been stretched and could possibly break. Gently remove and discard both the catheter and coil.

• Due to the delicate nature of the coils, the tortuous vascular pathways which lead to certain aneurysms and vessels, and the varying morphologies of intracranial aneurysms, a coil may occasionally stretch while being maneuvered. Stretching is a precursor to potential malfunctions, such as coil breakage and migration.

• The long term effect of this product on extravascular tissues has not been established so care should be taken to retain this device in the intravascular space.

CAUTIONS / PRECAUTIONS

• Federal Law (USA) restricts this device to sale by or on the order of a physician.

• Exercise caution during placement of small coils at the base of any aneurysm. When accessing aneurysms, the diameter of the first or second coils should never be less than the width of the ostium, given the potential for these coils to migrate.

• GDC®-18 360° Detachable Coils should only be delivered through Boston Scientific "-18" 2-tip infusion catheter. GDC®-10 360° Detachable Coils and GDC-10 360° Soft Detachable Coils should only be delivered through Boston Scientific "-10" infusion catheters. If advanced through a Boston Scientific "-18" catheter, the GDC-10 Detachable Coil could fold back upon itself resulting in jamming, stretching or breaking.

• GDC-18 360° Detachable Coil is designed to be delivered through a Boston Scientific 2-tip infusion catheter. The compatibility of the GDC Detachable Coil system with other catheters and with other coil delivery devices has not been established.

• Advance and retract the coil slowly and smoothly, especially in tortuous anatomy. Remove the coil if unusual friction or "scratching" is noted. If friction is noted in a second coil, carefully examine both coil and the catheter for possible damage such as catheter shaft buckling or kinking, or improperly fused joint.

• Do not advance the coil with force if the coil becomes lodged within or outside the 2-tip infusion catheter. Determine the cause of resistance and remove the system when necessary.

• If resistance is encountered when withdrawing the delivery wire, draw back on the infusion catheter simultaneously until the delivery wire can be removed without resistance.

• If resistance is noted during coil delivery, remove the catheter/coil system and check for possible damage to the catheter.

• Use only the InZone® Detachment System (M00345100940) or a Boston Scientific Power Supply (M00345100740 or M00345100840) to detach GDC 360° Coils. Do not use other power sources.

• Do not sterilize the Boston Scientific Power Supply.

• Needle must not be coated.

• Verify that red Boston Scientific Power Supply connecting cable is connected to the GDC Detachable Coil's delivery wire, and the black Boston Scientific Power Supply connecting cable is connected to the sterilized hypodermic needle. If these connections are reversed, GDC Coils will not detach.

• In some ECG equipment, perturbations may be observed immediately before illumination of detachment indicator light on the Boston Scientific Power Supply.

• DO NOT PRESS THE ON/OFF BUTTON until after verification under fluoroscopy that the coil has detached.

• If the patient experiences pain at the site of the patient return electrode, or if detachment times are increasing, replace the return electrode with a new needle at a new insertion site.

• Incorrect placement of batteries could result in unit malfunction.

• High quality, digital subtraction fluoroscopic road mapping is mandatory to achieve safe catheterization of the aneurysm or vessel and correct placement of the first coil.With smaller aneurysms this is particularly important.

• If resistance is encountered while withdrawing a coil which is at an acute angle relative to the catheter tip, it is possible to avoid coil stretching or breaking by carefully repositioning the distal tip of the catheter at the ostium of the aneurysm, or just slightly inside the parent artery. By doing so, the aneurysm and artery act to "funnel" the coil back into the catheter.

• Take care not to puncture gloves or sterile drape while handling the delivery wire.

• Multiple embolization procedures may be required to achieve the desired occlusion of some aneurysms or vessels.

• The safety and performance characteristics of the GDC 360° System (GDC 360° Detachable Coils, Boston Scientific Detachable Coil Power Supply, InZone Detachment System, delivery systems, and accessories), when used with another manufacturer's devices (whether coils, coil delivery devices, catheters, guidewires, and/or other accessories) has NOT been established. Due to the potential incompatibility of non-Boston scientific components with the GDC 360° System, the use of another manufacturer's device(s) with the GDC 360° System is not recommended.

InZone® Detachment System

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InZone® Detachment System


InZone® Detachment System is manufactured by Boston Scientific for Stryker Neurovascular.

The Cutting Edge in Electrolytic Detachment.

The Formula for Exceptional Performance
Introducing a revolutionary formula for product development. With Tenzing™ Technology, quality, process and design come together to create a platform where no single feature stands alone. Each element has been optimized to work together, resulting in exceptional performance.

Experience Tenzing Technology.

90582380.AC



Features & Benefits



Ready. Set. Detached.
Fast detachments and real-time feedback are just a click away with an advanced interface that keeps you up to speed

Fast Detachments
With the InZone Detachment System, Target™ Detachable Coils can detach in seconds

Quick Setup
No cables, needles or battery changes are required when used with Target Detachable Coils

Direct Feedback
Visual and audio signals depict and facilitate the detachment process through changes in position, color and tone

Sterile Field Operation
Physician has full control with this single-use device

Backwards Compatibility
The InZone Detachment System is capable of detaching all Boston Scientific Neurovascular coils

Single-Button Activation
One click is all it takes to begin coil detachment

Kullanım Talimatları

INDICATIONS FOR USE
The InZone Detachment System is intended for use with all versions of Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

CONTRAINDICATIONS
None known.

POTENTIAL ADVERSE EFFECTS
No adverse events are associated with the use of the InZone Detachment System as a stand alone device. Refer to Boston Scientific Detachable Coil Directions for Use for adverse events associated with the use of Boston Scientific detachable coils. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.
Please notify your Boston Scientific representative immediately if a device malfunctions or patient complication or injury is experienced or suspected associated with the use of this device. Please make every attempt to retain any suspect device, its associated components and their packaging for return to Boston Scientific.

WARNINGS

• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.

• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• This device should only be used by physicians who have received appropriate training in interventional neuroradiology or interventional radiology and preclinical training on the use of this device as established by Boston Scientific.

• The InZone Detachment System can only be used with Boston Scientific Detachable Coils (Target®, GDC® and Matrix2®) and the IZDS® Connecting Cable. DO NOT SUBSTITUTE any components or devices from other manufacturers or injury to the patient or user could result.

• Advancing the coil delivery wire beyond the microcatheter tip once the coil has detached may increase the risk of aneurysm or vessel rupture.

• Sliding the detachment system with too much force or failing to tighten the microcatheter RHV prior to detachment may cause the delivery wire to kink or result in displacement of the coil and/or microcatheter tip in the vessel, which could lead to failed detachment, suboptimal coil position post-detachment, vessel perforation, aneurysm perforation, pseudoaneurysm and aneurysm rupture. Do not advance the
InZone Detachment System over the coil delivery wire against significant resistance.

• After use, the InZone Detachment System (excluding packaging) should be handled and processed as biohazardous material. After use, dispose of the InZone Detachment System unit in accordance with hospital, administrative and/or local government policy for the handling, processing and disposal of biohazardous materials. Dispose of packaging, delivery wires, introducer sheaths, IZDS Connecting Cable (UPN M00345110250, if applicable) and needle (if applicable) in accordance with hospital, administrative and/or local government policy.

CAUTIONS

• Federal Law (USA) restricts this device to sale by or on the order of a physician.

• Prior to beginning a procedure, confirm that there are enough detachment systems on the shelf to complete the anticipated number of detachments required. In addition, one extra InZone® Detachment System is required as backup for all procedures. Verify that the InZone Detachment Systems to be used are within their indicated shelf life.

• One extra IZDS® Connecting Cable (UPN M00345110250) and sterile 20- or 22-gauge uncoated stainless steel hypodermic needle are required as backup for all procedures using the InZone Detachment System to detach GDC® or Matrix2® Detachable Coils. Verify that the cables and needles to be used are within their indicated shelf life.

• While it is essential to sufficiently tighten the microcatheter RHV around the coil delivery wire prior to using the InZone Detachment System, over-tightening the RHV could cause the delivery wire to kink.

• Batteries are pre-loaded into the InZone Detachment System. Do not attempt to replace batteries or open the enclosure.

• Increased detachment times may occur when:


-

Other embolic agents are present.

-

Delivery wire and microcatheter markers are not properly aligned.

-

Thrombus is present on the coil detachment zone.

-

The IZDS® Connecting Cable has been resterilized. The IZDS Connecting Cable is supplied for one use only and should be discarded after each procedure (Only applicable when detaching GDC® or Matrix2® Detachable Coils).

• If device is set down, take care to gently place it in a stable position so that it does not slide off of the delivery wire during detachment. If device is held, take care to gently hold it in a stable position so that it does not slide off of the delivery wire during detachment.

• In some ECG equipment, perturbations may be observed immediately before illumination of the DETACHMENT DETECTION indicator on the InZone® Detachment System.

• Because coils are not always detached following completion of a cycle, ALWAYS verify under fluoroscopy that the coil has detached by slowly pulling back on the delivery wire while monitoring the fluoro image to make sure there is no movement of the coil. In the unlikely event the coil moves (indicating it is still attached to the delivery wire), check and adjust the flush system, check and adjust the grounding setup (only applicable when detaching GDC or Matrix2 Detachable Coils), realign the delivery wire with the microcatheter, tighten the RHV and repeat the detachment procedure.

• Needle must not be coated.

• If the patient experiences pain at the site of the needle, or if detachment times are increasing, replace the needle with a new needle at a new insertion site.

• The IZDS Connecting Cable is intended for single patient use only. Do not resterilize and/or reuse. Resterilization could corrode the connecting cable, resulting in increased detachment times.

• Disconnection or poor connection of any part of the grounding setup after the detachment system indicates SYSTEM READY may result in an inability to detach GDC or Matrix2 Detachable Coils.

• The safety and performance characteristics of the InZone Detachment System when used with another manufacturer’s devices (whether coils, coil delivery devices, catheters, guidewires and/or other accessories), have NOT been established. Due to the potential incompatibility of non-Boston Scientific components with the InZone Detachment System, the use of another manufacturer’s device(s) with the InZone Detachment System is not recommended.

Target® Detachable Coils

Açıklamalar


Target® Detachable Coils with Tenzing™ Technology


Target® Detachable Coils with Tenzing™ Technology are manufactured by Boston Scientific for Stryker Neurovascular.

Advance with Confidence.

The Formula for Exceptional Performance
Introducing a revolutionary formula for product development. With Tenzing Technology, quality, process, and design come together to create a platform where no single feature stands alone. Each element of the Target Detachable Coil system has been optimized to work together, resulting in exceptional coil performance.

Experience Tenzing Technology.

90645804.AB


Features & Benefits


Balanced Design
Engineered to optimize both pushability and flexibility, resulting in a new level of tactile sensation.

Controlled Delivery
Experience the difference throughout the entire delivery process – from enhanced trackability through the microcatheter, to smoother coil positioning, and improved stability upon marker alignment.

Target® 360 Ultra Coil
Our softest complex coil ever, the Target 360 Ultra Detachable Coil unites finishing-coil softness with the Gold Standard in shape. Experience the benefits of 360 from Start to Finish.

Ready. Set. Detached.
Fast detachments† and real-time feedback are just a click away with an advanced interface that keeps you up to speed.

1. COMPREHENSIVE OFFERING
Target Coil family provides an expanded suite of 10-size 360 and helical coils, including longer lengths and the first bare complex finishing coil in the Target 360 Ultra Detachable Coil

2. FLEXIBLE JUNCTION
Softer, shorter junction engineered to minimize kickback for increased control and stability

3. LASER-ABLATED DETACHMENT ZONE
New design uses 82% less metal for fast detachments with no compromise to tensile strength

4. DARKER RADIOPAQUE MARKER
Enhances visibility to facilitate accurate alignment

5. BIPOLAR PATHWAY
Centralized electrodes allow for quicker system setup by eliminating the need for a grounding cable and needle

6. HYBRID DELIVERY WIRE
Balanced stiffness zones provide an optimized combination of flexibility and pushability to yield a one-to-one feel

7. FLUORO-SAVER MARKER
Intended to reduce radiation exposure time for physicians and patients

8. INZONE DETACHMENT SYSTEM
Streamlines detachment process with increased speed, direct feedback, and greater control


† Average < 5 seconds based on bench test data (n=22).

Bench test results may not necessarily be indicative of clinical performance. Testing completed by Boston Scientific Corporation. Data on file and available upon request.

* Bench testing data (n=22).

All photographs taken by and on file at Boston Scientific Corporation.

Kullanım Talimatları

INDICATIONS FOR USE:

Target Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Target Coils are indicated for endovascular embolization of:

• Intracranial aneurysms.

• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

• Arterial and venous embolizations in the peripheral vasculature.

CONTRAINDICATIONS:

None known.

POTENTIAL ADVERSE EVENTS:

Potential complications include, but are not limited to: Aneurysm perforation and rupture, arrhythmia, death, edema, embolus, headache, hemorrhage, infection, ischemia, neurological / intracranial sequelae, post-embolization syndrome (fever, increased white blood cell count, discomfort), TIA / stroke, vasospasm, vessel occlusion or closure, vessel perforation, dissection, trauma or damage, vessel rupture, vessel thrombosis and other procedural complications including but not limited to anesthetic and contrast media risks, hypotension, hypertension and access site complications. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Please notify your Boston Scientific representative immediately if a device malfunctions or patient complication or injury is experienced or suspected associated with the use of this device. Please make every attempt to retain any suspect device, its associated components and their packaging for return to Boston Scientific.

WARNINGS:

• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.

• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

• This device should only be used by physicians who have received appropriate training in interventional neuroradiology or interventional radiology and preclinical training on the use of this device as established by Boston Scientific.

• Patients with hypersensitivity to 316LVM stainless steel may suffer an allergic reaction to this implant

• MR temperature testing was not conducted in peripheral vasculature, arteriovenous malformations or fistulae models.

• The safety and performance characteristics of the Target Detachable Coil System (Target Coils, InZone® Detachment Systems, delivery systems and accessories) have not been demonstrated with other manufacturer’s devices (whether coils, coil delivery devices, coil detachment systems, catheters, guidewires and/or other accessories). Due to the potential incompatibility of non Boston Scientific devices with the Target Coil System, the use of other manufacturer’s device(s) with the Target Coil System is not recommended.

• To reduce risk of coil migration, the diameter of the first and second coil should never be less than the width of the ostium.

• In order to achieve optimal performance of the Target Detachable Coil System and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters and c) the 2-tip microcatheter and Boston Scientific guidewire and delivery wire. Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the Target Detachable Coil.

• Do not use the product after the “Use By” date specified on the package.

• Reuse of the flush port/dispenser coil or use with any coil other than the original coil may result in contamination of or damage to, the coil.

• Damaged delivery wires may cause detachment failures, vessel injury or unpredictable distal tip response during coil deployment. If a delivery wire is damaged at any point during the procedure, do not attempt to straighten or otherwise repair it. Do not proceed with deployment or detachment. Remove the entire coil and replace with undamaged product.

• Utilization of damaged coils may affect coil delivery to, and stability inside, the vessel or aneurysm, possibly resulting in coil migration and/or stretching.

• The fluoro-saver marker is designed for use with a Rotating Hemostatic Valve (RHV). If used without an RHV, the distal end of the coil may be beyond the alignment marker when the fluoro-saver marker reaches the microcatheter hub.

• If the fluoro-saver marker is not visible, do not advance the coil without fluoroscopy.

• Do not rotate delivery wire during or after delivery of the coil. Rotating the Target Coil delivery wire may result in a stretched coil or premature detachment of the coil from the delivery wire, which could result in coil migration.

• Verify there is no coil loop protrusion into the parent vessel after coil placement and prior to coil detachment. Coil loop protrusion after coil placement may result in thromboembolic events if the coil is detached.

• Verify there is no movement of the coil after coil placement and prior to coil detachment. Movement of the coil after coil placement may indicate that the coil could migrate once it is detached.

• Failure to properly close the RHV compression fitting over the delivery wire before attaching the InZone® Detachment System could result in coil movement, aneurysm rupture or vessel perforation.

• Verify repeatedly that the distal shaft of the catheter is not under stress before detaching the Target® Detachable Coil. Axial compression or tension forces could be stored in the 2-tip microcatheter causing the tip to move during coil delivery. Microcatheter tip movement could cause the aneurysm or vessel to rupture.

• Advancing the delivery wire beyond the microcatheter tip once the coil has been detached involves risk of aneurysm or vessel perforation.

• The long term effect of this product on extravascular tissues has not been established so care should be taken to retain this device in the intravascular space.

CAUTIONS:

• Federal Law (USA) restricts this device to sale by or on the order of a physician.

• Besides the number of InZone Detachment System units needed to complete the case, there must be an extra InZone Detachment System unit as back up.

• Removing the delivery wire without grasping the introducer sheath may result in the delivery wire and detachable coil sliding out of the introducer sheath.

• Failure to remove the introducer sheath after inserting the delivery wire into the RHV of the microcatheter will interrupt normal infusion of flush solution and allow back flow of blood into the microcatheter.

• Some low level overhead light near or adjacent to the patient is required to visualize the fluoro-saver marker; monitor light alone will not allow sufficient visualization of the fluoro-saver marker.

• Advance and retract the Target Detachable Coil carefully and smoothly without excessive force. If unusual friction is noticed, slowly withdraw the Target Coil and examine for damage. If damage is present, remove and use a new Target Coil. If friction or resistance is still noted, carefully remove the Target Coil and microcatheter and examine the microcatheter for damage.

• If it is necessary to reposition the Target Coil, verify under fluoroscopy that the coil moves with a one-to-one motion. If the coil does not move with a one-to-one motion or movement is difficult, the coil may have stretched and could possibly migrate or break. Gently remove both the coil and microcatheter and replace with new devices.

• Increased detachment times may occur when:

- Other embolic agents are present.

- Delivery wire and microcatheter markers are not properly aligned.

- Thrombus is present on the coil detachment zone.

• Do not use detachment systems other than the InZone Detachment System.

Trevo® Pro Retrieval System

Açıklamalar


Trevo Pro Retrieval System by Concentric Medical


Because Integration Matters

The first device featuring Stentriever® Technology specifically for stroke and for maximizing clot integration.

90817861.AA


Vertical Strut Orientation
Innovative strut orientation designed for efficient clot integration and confident retrieval.

Tailored Radial Force
Dual-zone radial force quickly integrates and secures clots across a broad range of vessel diameters.

Spiral Cell Design with No Cell Overlap
Tubular design resists kinking and maximizes clot integration regardless of vessel tortousity.


Wide cell Area
for optimized clot integration across clot types.
&
Soft, Guidewire-like Tip
for safe and accurate deployment.


One size, all vessels
TREVO 2 Clinical Trial data demonstrates outstanding revascularization rates in the Anterior and Posterior circulation.

Procedures Simplified
Complete system with all components optimized to work together from the company that pioneered DAC® Catheter technology and balloon guide catheters to support ischemic stroke cases.
Trevo® Pro Retriever and Trevo® Pro 18 Microcatheter packaged together in a kit for added convenience
Full family of DAC Catheters for easy access, navigation and support
Balloon Guide Catheter for flow arrest

Kullanım Talimatları

TREVO® RETRIEVER

See package insert for complete indications, contraindications, warnings and instructions for use.

INDICATIONS FOR USE:
The Trevo® Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

POTENTIAL ADVERSE EVENTS:
Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with possible complications which may occur during or after the procedure. Possible complications include, but are not limited to, the following: air embolism; hematoma or hemorrhage at puncture site; infection; distal embolization; vessel spasm, thrombosis, dissection, or perforation; emboli; acute occlusion; ischemia; intracranial hemorrhage; false aneurysm formation; neurological deficits including stroke; and death.

WARNINGS:
Contents supplied STERILE, using an ethylene oxide (EO) process. Nonpyrogenic.
To reduce risk of vessel damage, adhere to the following recommendations:
Take care to appropriately size Retriever to vessel diameter at intended site of deployment.
Do not perform more than six (6) retrieval attempts in same vessel using Retriever devices
Maintain Retriever position in vessel when removing or exchanging Microcatheter. To reduce risk of fracture, adhere to the following recommendations:

Immediately after unsheathing Retriever, position Microcatheter tip marker just proximal to shaped section. Maintain Microcatheter tip marker just proximal to shaped section of Retriever during manipulation and withdrawal.
Do not rotate or torque Retriever.
Use caution when passing Retriever through stented arteries.
Do not resterilize and reuse. Structural integrity and/or function may be impaired by reuse or cleaning.
The Retriever is a delicate instrument and should be handled carefully. Before use and when possible during procedure, inspect device carefully for damage. Do not use a device that shows signs of damage. Damage may prevent device from functioning and may cause complications.
Do not advance or withdraw Retriever against resistance or significant vasospasm. Moving or torquing device against resistance or significant vasospasm may result in damage to vessel or device. Assess cause of resistance using fluoroscopy and if needed resheath the device to withdraw.
If Retriever is difficult to withdraw from the vessel, do not torque Retriever. Advance Microcatheter distally, gently pull Retriever back into Microcatheter, and remove Retriever and Microcatheter as a unit. If undue resistance is met when withdrawing the Retriever into the Microcatheter, consider extending the Retriever using the Abbott Vascular DOC® guidewire extension (REF 22260) so that the Microcatheter can be exchanged for a larger diameter catheter such as a DAC® catheter. Gently withdraw the Retriever into the larger diameter catheter.
Administer anti-coagulation and anti-platelet medications per standard institutional guidelines.

PRECAUTIONS:
Prescription only - device restricted to use by or on order of a physician.
Store in cool, dry, dark place.
Do not use open or damaged packages.
Use by "Use By" date.
Exposure to temperatures above 54°C (130°F) may damage device and accessories. Do not autoclave.
Do not expose Retriever to solvents. • Use Retriever in conjunction with fluoroscopic visualization and proper anti-coagulation agents.
To prevent thrombus formation and contrast media crystal formation, maintain a constant infusion of appropriate flush solution between guide catheter and Microcatheter and between Microcatheter and Retriever or guidewire.
Do not attach a torque device to the shaped proximal end of DOC® Compatible Retriever. Damage may occur, preventing ability to attach DOC® Guide Wire Extension.

TREVO® PRO 18 MICROCATHETER
See package insert for complete indications, contraindications, warnings and instructions for use.

INDICATIONS FOR USE:
The Trevo® Pro 18 Microcatheter is indicated for use in the selective placement of fluids and/ or other devices or agents into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

POTENTIAL ADVERSE EVENTS:
Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications. Possible complications include, but are not limited to the following: hematoma at the puncture site; vessel perforation; emboli; hemorrhage; ischemia; vasospasm; neurological deficits including stroke; death.

WARNINGS:
Do not reuse. Discard after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning.
Never advance catheter against resistance without careful assessment of cause using fluoroscopy. If cause cannot be determined, withdraw catheter. Movement against resistance may result in damage to vessel or catheter.
Do not use device that has been damaged in any way. Damaged device may cause complications.
Do not exceed maximum recommended infusion pressure. Excess pressure may result in catheter rupture or tip severance. If flow through catheter becomes restricted, do not attempt to clear catheter lumen by infusion. Doing so may cause catheter to rupture, resulting in vessel trauma. Remove and replace catheter.

PRECAUTIONS:
Store in cool, dry, dark place.
Do not use open or damaged packages.
Use by "Use By" date.
Exposure to temperatures above 54°C (130°F) may damage device and accessories. Do not autoclave.
Upon removal from package, inspect device to ensure it is not damaged. • Do not expose device to solvents.
Use device with fluoroscopic visualization and proper anti-coagulation agents.
Hydrate microcatheter with saline for 2 minutes minimum before use. Once hydrated, do not allow it to dry.
To maintain hydrophilic coating lubricity, provide continuous flow of appropriate solution between microcatheter and guide catheter.
Hemostatic side-arm adapters may be used to provide seal around guidewire and microcatheter.

Merci® Balloon Guide Catheter
See package insert for complete indications, contraindications, warnings and instructions for use.

INDICATIONS FOR USE:
Concentric and Merci Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

POTENTIAL ADVERSE EVENTS:
Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications. Possible complications include, but are not limited to, the following: infection, hematoma, distal embolization, vessel thrombosis, dissection, false aneurysm formation, acute occlusion, clot formation, hemorrhage at the puncture site, intracranial hemorrhage, arterial rupture, stroke and death.

WARNINGS:
Do not reuse. Discard after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning.
Never advance or torque catheter against resistance without careful assessment of cause of resistance using fluoroscopy. If cause cannot be determined, withdraw catheter. Movement against resistance may result in damage to vessel or catheter.
To reduce risk of complications due to slow balloon deflation, adhere to the following recommendations:
Wet distal shaft with saline before passing into introducer sheath.
Minimize pushing forces on shaft during advancement. These forces can cause wrinkles in shaft that can slow balloon deflation. - Do not use device if shaft is damaged during us
Prepare balloon according to Recommended Procedure.

To reduce risk of complications due to air emboli, remove air from balloon according to Recommended Procedure.
Withdrawing balloon through introducer sheath may damage balloon. Do not use catheter again after withdrawing balloon through introducer sheath.
To avoid balloon leakage, do not allow balloon to contact calcified or stented arteries and do not allow balloon to move during inflation.
Do not use a device that has been damaged. Use of damaged devices may result in complications.
Do not exceed maximum recommended balloon inflation volume. Excess inflation volume may rupture balloon.
For through-lumen, do not exceed 1896 kPa (275 psi) maximum recommended infusion pressure. Excess pressure may result in catheter rupture or tip detachment.
If flow through catheter becomes restricted, do not attempt to clear catheter lumen by infusion. Doing so may cause catheter to rupture, resulting in vessel trauma. Remove and replace catheter.
Do not steam shape guide catheter.

PRECAUTIONS:
Store in cool, dry, dark place.
Do not use open or damaged packages.
Use by "Use By" date.
Exposure to temperatures above 54°C (130°F) may damage device and accessories. Do not autoclave.
Upon removal from package, inspect device to ensure it is not damaged.
Do not expose device to solvents.
Use device in conjunction with fluoroscopic visualization and proper anticoagulation agents.
Torquing guide catheter while kinked may cause damage that could result in separation of catheter shaft.
If a device becomes lodged in guide catheter, or if guide catheter becomes severely kinked, withdraw entire system (guide catheter, guidewire and catheter sheath introducer).
To prevent thrombus formation and contrast media crystal formation, maintain a constant infusion of appropriate flush solution through guide catheter lumen.

Distal Access Catheter
See package insert for complete indications, contraindications, warnings and instructions for use.

INDICATIONS FOR USE:
The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

POTENTIAL ADVERSE EVENTS:
Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with possible complications. Possible complications include, but are not limited to, the following: hematoma at puncture site; infection; vessel perforation; air embolism; hemorrhage; ischemia; vasospasm; neurological deficits including stroke; death.

WARNINGS:
Do not reuse. Discard after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning.
Never advance catheter against resistance without careful assessment of cause using fluoroscopy. If cause cannot be determined, withdraw catheter. Movement against resistance may result in catheter damage or patient injury.
Do not use device that has been damaged in any way. Damaged device may cause complications.
Do not exceed 2070 kPa (300 psi) maximum recommended infusion pressure. Excess pressure may result in catheter damage or patient injury. Use of power injectors requires careful monitoring of catheter tip placement in the vasculature to avoid vessel damage.
If flow through catheter becomes restricted, do not attempt to clear catheter lumen by infusion. Doing so may cause catheter damage or patient injury. Remove and replace catheter.

PRECAUTIONS:
Store in cool, dry, dark place.
Do not use open or damaged packages.
Use by "Use By" date.
Exposure to temperatures above 54°C (130°F) may damage device and accessories. Do not autoclave.
Upon removal from package, inspect device to ensure it is not damaged.
Do not expose device to solvents.
Use device with fluoroscopic visualization and proper anti-coagulation agents.
Hydrate microcatheter with saline for 2 minutes minimum before use. Once hydrated, do not allow it to dry.
Torquing the catheter while kinked may cause damage which could result in separation of the catheter shaft.
If intraluminal device becomes lodged in catheter, or if the catheter becomes severely kinked, withdraw the entire system (intraluminal device, catheter and introducer sheath).

Trevo® ProVue™ Retrieval System

Açıklamalar


Trevo ProVue Retriever


Seeing is Retrieving™

Trevo® ProVue™ is the first and only fully visible device with Stentriever Technology, which allows physicians to view placement and strut behavior, thereby setting a new standard in precision and retrieval.

90817862.AA



Features & Benefits

See the Positioning
Visualize deployment and accurate placement


See the Interaction
Visualize expansion of struts to understand clot integration upon deployment

See the Retrieval
Visible Under Fluoroscopy for accurate placement and observable clot interaction

See the Integration

Vertical Strut Orientation
Innovative strut orientation designed specifically for efficient clot integration and confident retrieval

Tailored Radial Force
Dual-zone radial force quickly integrates and secures clot across a broad range of vessel diameters

Wide Cell Area
Promotes optimized integration – especially important for hard clots

Sprial Cell Alignment with No Cell Overlap
Tubular design resists kicking and maximizes clot integration, regardless of vessel tortuosity


One Size, All Vessels
Post-device revascularization by occlusion location
Pooled analysis of TREVO/TREVO 2 Clinical Trial data demonstrates outstanding revascularization rates in the Anterior and Posterior circulation

Kullanım Talimatları

INDICATIONS FOR USE:

The Trevo® Retriever is intended to restore blood ?ow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

COMPLICATIONS:

Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with possible complications which may occur during or after the procedure. Possible complications include, but are not limited to, the following: air embolism; hematoma or hemorrhage at puncture site; infection; distal embolization; vessel spasm, thrombosis, dissection, or perforation; emboli; acute occlusion; ischemia; intracranial hemorrhage; false aneurysm formation; neurological de?cits including stroke; and death.

COMPATIBILITY:

Retrievers are compatible with Trevo® Microcatheters (REF 90238). Compatibility of the Retriever with other microcatheters has not been established. Performance of the Retriever device may be impacted if a different microcatheter is used. The Merci® Balloon Guide Catheters are recommended for use during thrombus removal procedures. Retrievers are compatible with the Abbott Vascular DOC® Guide Wire Extension (REF 22260).

WARNINGS:
Contents supplied STERILE, using an ethylene oxide (EO) process. Nonpyrogenic.


To reduce risk of vessel damage, adhere to the following recommendations:

• Take care to appropriately size Retriever to vessel diameter at intended site of deployment.
• Do not perform more than six (6) retrieval attempts in same vessel using Retriever devices.
• Maintain Retriever position in vessel when removing or exchanging Microcatheter
To reduce risk of kinking/fracture, adhere to the following recommendations:


• Immediately after unsheathing Retriever, position Microcatheter tip marker just proximal to shaped section.
• Maintain Microcatheter tip marker just proximal to shaped section of Retriever during manipulation and withdrawal.
• Do not rotate or torque Retriever.
• Use caution when passing Retriever through stented arteries.
Do not resterilize and reuse. Structural integrity and/or function may be impaired by reuse or cleaning.


The Retriever is a delicate instrument and should be handled carefully. Before use and when possible during procedure, inspect device carefully for damage. Do not use a device that shows signs of damage. Damage may prevent device from functioning and may cause complications.


Do not advance or withdraw Retriever against resistance or signi?cant vasospasm. Moving or torquing device against resistance or signi?cant vasospasm may result in damage to vessel or device. Assess cause of resistance using ?uoroscopy and if needed resheath the device to withdraw.


If Retriever is dif?cult to withdraw from the vessel, do not torque Retriever. Advance Microcatheter distally, gently pull Retriever back into Microcatheter, and remove Retriever and Microcatheter as a unit. If undue resistance is met when withdrawing the Retriever into the Microcatheter, consider extending the Retriever using the Abbott Vascular DOC guidewire extension (REF 22260) so that the Microcatheter can be exchanged for a larger diameter catheter such as a DAC® catheter. Gently withdraw the Retriever into the larger diameter catheter.


Administer anti-coagulation and anti-platelet medications per standard institutional guidelines.

PRECAUTIONS:
Prescription only – device restricted to use by or on order of a physician.


Store in cool, dry, dark place. Do not use open or damaged packages.


Use by “Use By” date. Exposure to temperatures above 54°C (130°F) may damage device and accessories.


Do not autoclave. Do not expose Retriever to solvents.


Use Retriever in conjunction with ?uoroscopic visualization and proper anticoagulation agents.


To prevent thrombus formation and contrast media crystal formation, maintain a constant infusion of appropriate ?ush solution between guide catheter and Microcatheter and between Microcatheter and Retriever or guidewire.


Do not attach a torque device to the shaped proximal end of DOC® Compatible Retriever. Damage may occur, preventing ability to attach DOC® Guide Wire Extension.

Tracker ® -17 Microcatheter

Açıklamalar


Designed to Deliver

Balanced Trackability

Excellent Stability

Comprehensive Device Compatibility

NV00003003.AA



Features & Benefits



Balanced Trackability

Of the evaluated devices, the Tracker-17 (15cm) Microcatheter is the most trackable through a tortuous path.

Excellent Stability

Two tip configurations provide stability options for consistent coiling without rigidity.

Comprehensive Device Compatibility

The .017in ID and 1.9F/2.4F OD allows broad compatibility for use from start to finish.

Bench test results may not necessarily be indicative of clinical performance. Testing completed by Stryker Neurovascular. Data on file and available upon request.

Kullanım Talimatları

INTENDED USE / INDICATIONS FOR USE
Stryker Neurovascular’s Tracker-17 Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the neurovasculature.

CONTRAINDICATIONS
None known.

POTENTIAL ADVERSE EVENTS
Potential adverse events associated with the use of microcatheters or with the endovascular procedures include, but are not limited to: access site complications, allergic reaction, aneurysm perforation, aneurysm rupture, death, embolism (air, foreign body, plaque, thrombus), hematoma, hemorrhage, infection, ischemia, neurological deficits, pseudoaneurysm, stroke, transient ischemic attack, vessel dissection, vessel occlusion, vessel perforation, vessel rupture, vessel thrombosis, vasospasm.

WARNINGS
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Stryker Neurovascular representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
These devices are intended for use only by physicians trained in performing endovascular procedures.
The accessories are not intended for use inside the human body.
Limited testing has been performed with solutions such as contrast media, saline and suspended embolic particles. The use of these microcatheters for delivery of solutions other than the types that have been tested for compatibility is not recommended. Do not use with glue or glue mixtures.
Carefully inspect all devices prior to use. Verify shape, size and condition are suitable for the specific procedure.
Exchange microcatheters frequently during lengthy procedures that require extensive guidewire manipulation or multiple guidewire exchanges.
Never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy. Movement of the microcatheter or guidewire against resistance could dislodge a clot, perforate a vessel wall, or damage microcatheter and guidewire. In severe cases, tip separation of the microcatheter or guidewire may occur.
Inspect product before use for any bends, kinks or damage. Do not use a microcatheter that has been damaged. Damaged microcatheters may rupture causing vessel trauma or tip detachment during steering maneuvers.
Shaping mandrel is not intended for use inside the human body.
Discontinue use of microcatheter for infusion if increased resistance is noted. Resistance indicates possible blockage. Remove and replace blocked microcatheter immediately. DO NOT attempt to clear blockage by over-pressurization. Doing so may cause the microcatheter to rupture, resulting in vascular damage or patient injury.
Do not exceed 2,070 kPa (300 psi) infusion pressure. Excessive pressure could dislodge a clot, causing thromboemboli, or could result in a ruptured microcatheter or severed tip, causing vessel injury.

CAUTIONS / PRECAUTIONS
Federal Law (USA) restricts this device to sale by or on the order of a physician.
To reduce the probability of coating damage in tortuous vasculature, use a guide catheter with a minimum internal diameter as specified in the DFU, and is recommended for use with Stryker Neurovascular hydrophilically coated microcatheters.
To control the proper introduction, movement, positioning and removal of the microcatheter within the vascular system, users should employ standard clinical angiographic and fluoroscopic practices and techniques throughout the interventional procedure.
Exercise care in handling of the microcatheter during a procedure to reduce the possibility of accidental breakage, bending or kinking.
Use the product prior to the “Use By” date printed on the label.
Flush dispenser coil of hydrophilically coated microcatheters prior to removal from dispenser coil. Once the microcatheter has been wetted, do not allow to dry. Do not reinsert the microcatheter into dispenser coil.
Do not position microcatheter closer than 2.54cm (1in) from the steam source. Damage to the microcatheter may result.
Check that all fittings are secure so that air is not introduced into guide catheter or microcatheter during continuous flush.
In order to achieve optimal performance of Stryker Neurovascular Microcatheters and to maintain the lubricity of the Hydrolene® Coating surface, it is critical that a continuous flow of appropriate flush solution be maintained between the Stryker Neurovascular Microcatheter and guide catheter, and the microcatheter and any intraluminal device. In addition, flushing aids in preventing contrast crystal formation and/or clotting on both the intraluminal device and inside the guide catheter and/or the microcatheter lumen.
Excessive tightening of a hemostatic valve onto the microcatheter shaft may result in damage to the microcatheter.
To facilitate microcatheter handling, the proximal portion of the microcatheter does not have the hydrophilic surface. Greater resistance may be encountered when this section of the microcatheter is advanced into the RHV.

TransForm™ Occlusion Balloon Catheter

Açıklamalar


TransForm™ Occlusion Balloon Catheter


Take Control.
Elevate Performance.

NV00001888.AA



Features & Benefits

 



Superior Navigability
Excellent Stability
Optimal Visibility

Super Compliant Occlusion Balloon Catheter
Designed for extra softness and conformability to conform to irregular, complex vasculature

Compliant Occlusion Balloon Catheter
Optimal compliance provides greater neck coverage, ideal for treatment of sidewall aneurysms

Reduced Fluroscope Time
Provided by the proximal fluro saver marker

 

Kullanım Talimatları

INTENDED USE / INDICATIONS FOR USE
The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.

CONTRAINDICATIONS
None known.

POTENTIAL ADVERSE EVENTS
Potential adverse events associated with the use of balloon catheters or with the endovascular procedures include, but are not limited to: access site complications, allergic reaction, aneurysm perforation, aneurysm rupture, death, embolism (air, foreign body, plaque, thrombus), hematoma, hemorrhage, infection, ischemia, neurological deficits, pseudoaneurysm, stroke, transient ischemic attack, vasospasm, vessel dissection, vessel occlusion, vessel perforation, vessel rupture, vessel thrombosis.

WARNINGS
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Stryker Neurovascular representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
These devices should only be used by physicians who have received appropriate training in neurointerventional surgery, interventional neuroradiology or interventional radiology.
Use only with appropriate inflation media (of saline and contrast solution mixture). Do not use oil-based contrast agents such as Lipiodol® or Ethiodol®. Use of these contrast agents can damage the balloon.
The compatibility of the TransForm Occlusion Balloon Catheter has not been evaluated with polyvinyl alcohol (PVA) particles or n-butyl cyanoacrylate (n-BCA). • The balloon catheter is not intended to be used as an infusion catheter, for embolectomy or subselective angiography. The balloon may inadvertently inflate if used for these types of procedures.
Presence of implanted devices such as clips and stents, and anatomical structures or irregularities such as bone fragments or calcifications, may damage the balloon or prevent entry/removal.
Do not steam shape the catheter tip, as heat may damage the balloon material.
The balloon should never be inflated or deflated with a pressure-based inflation device. • Carefully inspect the balloon catheter prior to use. If product is damaged do not use and contact your Stryker Neurovascular representative. Use of a damaged catheter may cause serious injury.
Verify device size, configuration and patient conditions are suitable for the specific procedure.
Prior to introducing the balloon catheter system into the vasculature purge the system carefully to avoid accidental introduction of air into the balloon catheter system. Failure to do so may release trapped air during device use and cause neurological deficits. Do not perform initial balloon flush while in the vasculature.
Never advance or withdraw the balloon catheter system against resistance. Movement of device against resistance could dislodge a clot, perforate a vessel wall, or damage the device. If resistance is felt when advancing or removing the balloon catheter from the guide catheter, carefully remove them as a unit to prevent damage to the blood vessel, guide catheter or the device.
Do not inflate the balloon beyond the diameter of the vessel being treated or beyond the maximum allowed inflation volume (see tables 2-4). Excessive inflation volume may result in a ruptured balloon or damage to the vessel. Do not move the balloon catheter while the balloon is inflated.
Withdrawing the guidewire into the balloon catheter past the distal tip (e.g., in-vivo guidewire exchange, flushing the balloon, etc.) is not recommended due to the risk of blood entry into the balloon. Blood in the balloon may result in risk of serious injury due to poor balloon visualization and the potential of flushing embolic clots. If the guidewire is withdrawn into the balloon catheter past the distal tip, withdraw the entire balloon catheter system. Prior to reintroduction, prepare the balloon catheter system per the directions in the Prepare Occlusion Balloon Catheter steps.

CAUTIONS / PRECAUTIONS
Federal Law (USA) restricts this device to sale by or on the order of a physician.
The TransForm Occlusion Balloon Catheter is designed specifically for use with a Stryker Neurovascular 0.014 in (0.36 mm) guidewire. Compatibility with other guidewires has not been established.
To facilitate balloon catheter handling, the proximal portion of the balloon catheter does not have a hydrophilic surface. Greater resistance may be encountered when this section of the balloon catheter is advanced into the Rotating Hemostatic Valve (RHV).
Exercise care in handling the balloon catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking.
To control introduction, movement, positioning and removal of the balloon catheter within the vascular system, users should employ standard clinical angiographic and fluoroscopic practices and techniques throughout the interventional procedure.
The TransForm™ Occlusion Balloon Catheter has not been tested in coronary vessels.
The TransForm Occlusion Balloon Catheter is not intended for angioplasty treatment of intracranial atherosclerotic disease.
Use prior to the “Use By” date shown on the package label. Aging beyond use by date may result in material degradation resulting in adverse performance of the product.
Use caution while removing contents from packaging. Rapid removal or jerking from the package may cause catheter damage.
Do not reinsert the balloon catheter into the dispenser coil. Reinserting the balloon catheter into the dispenser coil may cause kinking or damage to the balloon catheter. Once the balloon catheter has been hydrated, do not allow to dry.

İSTANBUL ŞUBE


Adres : Kısıklı Mahallesi Reşatbey Sokak No:40/1-2 Üsküdar/İSTANBUL
Telefon : +90 216 481 96 13-14-15 Faks : +90 216 481 96 17
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İZMİR ŞUBE


Adres : 1438 Sokak no: 14/1    
Alsancak/İZMİR    
Telefon : + 90 232 4639075 - 4218937 - 4224824 Faks : + 90 232 4218937
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