Trevo NXT ProVue Retriever

RX ONLY

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

Intended use/indications for use

1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
2. 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.
3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age <80 years, 0-20 cc for age ≥80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

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, pain/headache, vessel spasm, thrombosis, dissection, perforation, emboli, acute occlusion, ischemia, intracranial hemorrhage, false aneurysm formation, neurological deficits including stroke, death.

Use of device requires fluoroscopy which presents potential risks to physicians and patients associated with x-ray exposure. Possible risks include, but are not limited to, the following: alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, delayed neoplasia.

Compatibility

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. Balloon Guide Catheters and Aspiration Catheters (commercially available aspiration catheters with minimum inner diameter 0.058in (1.47mm)) are recommended for use during thrombus removal procedures.

Warnings

Specific warnings for indication 1

• The safety and effectiveness of the Trevo Retrievers in reducing disability has not been established in patients with large core infarcts (i.e., ASPECTS ≥7). There may be increased risks, such as intracerebral hemorrhage, in these patients.
• The safety and effectiveness of the Trevo Retrievers in reducing disability has not been established or evaluated in patients with occlusions in the posterior circulation (e.g., basilar or vertebral arteries) or for more distal occlusions in the anterior circulation.

Specific warnings for indication 2

To reduce risk of vessel damage, take care to appropriately size Retriever to vessel diameter at intended site of deployment.

Specific warnings for indication 3

• The safety and effectiveness of the Trevo Retrievers in reducing disability has not been established in patients with large core infarcts (i.e., ASPECTS ≤7). There may be increased risks, such as intracerebral hemorrhage, in these patients.
• The safety and effectiveness of the Trevo Retrievers in reducing disability has not been established or evaluated in patients with occlusions in the posterior circulation (e.g., basilar or vertebral arteries) or for more distal occlusions in the anterior circulation.
• Users should validate their imaging software analysis techniques to ensure robust and consistent results for assessing core infarct size.

General warnings applied to all indications

• Administration of IV t-PA should be within the currently approved window.
• To reduce risk of vessel damage, adhere to the following recommendations
  • 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 or Aspiration Catheter tip marker over the proximal section of the Retriever. Maintain this position during manipulation and withdrawal.
  • Do not rotate or torque Retriever.
  • Use caution when passing Retriever through stented arteries.
• 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 or Aspiration Catheter over the Retriever and remove devices as a unit. If undue resistance is met when withdrawing the Retriever into the Microcatheter, consider exchanging for a larger diameter Aspiration Catheter. Gently withdraw the Retriever and larger diameter catheter as a unit.
• Administer anti-coagulation and anti-platelet medications per standard institutional guidelines.
• Do not use open or damaged packages.
• Do not expose Retriever to organic solvents.

Precautions

• Store in cool, dry, dark place.
• Use by “Use By” date.
• Exposure to temperatures above 54°C (130°F) may damage device and accessories. Do not autoclave.
• 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 through all catheter lumens.
• Users should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible.

AXS Vecta Aspiration System

RX ONLY

Intended use/indications for use

The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

Device description

The AXS Vecta Aspiration System is composed of the following components:

• AXS Vecta 71 or 74 Aspiration Catheter
• Medela Dominant Flex Pump
• AXS Universal Aspiration Tubing
• AXS Universal Liner Set.

The AXS Vecta Aspiration Catheter delivers aspiration from the Medela Dominant Flex Pump directly to the site of the occlusion to remove the clot. The AXS Vecta Aspiration Catheter is a single lumen, flexible, variable stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta Aspiration Catheter shaft has a lubricious hydrophilic coating at the distal end (distal 25cm) to reduce friction during use. It is packaged with one Scout Introducer, one hemostasis valve, and two peel-away introducers.

The Scout Introducer may be used in conjunction with the AXS Vecta Aspiration Catheter to facilitate in the introduction of the AXS Vecta Aspiration Catheter into distal vasculature and aid in navigation to distal anatomy. The Scout Introducer has a lubricious hydrophilic coating at the distal end to reduce friction during use. The inner lumen of the AXS Vecta Aspiration Catheter is compatible with the Scout Introducer, guide wires and microcatheters. The inner lumen of the Scout Introducer is compatible with guide wires and microcatheters of an outer diameter of less than 0.044in.

The AXS Universal Aspiration Tubing serves as a conduit to supply vacuum from the Medela Dominant Flex Pump to the distal tip of the AXS Vecta Aspiration Catheter. The AXS Universal Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the AXS Universal Aspiration Tubing is connected to the AXS Universal Liner Set (outside of the sterile environment) while the distal end of the AXS Universal Aspiration Tubing is connected to the AXS Vecta Aspiration Catheter (inside the sterile environment). The AXS Universal Liner Set is connected to the Medela Dominant Flex Pump (also outside of the sterile environment).

The Medela Dominant Flex Pump is designed to generate vacuum for the AXS Vecta Aspiration System. When used as part of the AXS Vecta Aspiration System, the AXS Vecta Aspiration Catheter requires a minimum vacuum pressure of -68 kPa [-20.08 in Hg] from the Medela Dominant Flex Pump. The Medela Dominant Flex Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

The AXS Universal Liner Set is provided non-sterile and consists of an individually packaged canister liner and a ClotFinder specimen cup. The AXS Universal Liner Set is offered with and without a desiccant. The AXS Universal Liner Set is single-use and the repository for aspirated material.

Dimensions of the AXS Vecta Aspiration Catheter and Scout Introducer are included on the individual device label. The AXS Vecta Aspiration Catheters are available in 3 different lengths, the device configurations including the length of the Scout packaged with each catheter and the recommended Microcatheter length is presented in the table 1.0 below.

The AXS Vecta Aspiration System is recommended for use in the following vessel size ranges based on non-clinical testing. Refer to Table 2.0 below.

Contraindications

The AXS Vecta Aspiration Catheter has not been evaluated for use in the coronary vasculature.

Do not use automated high-pressure contrast injection equipment with the AXS Vecta Aspiration Catheter because it may damage the device.

Adverse events

Potential adverse events associated with the use of catheters or with the endovascular procedures include, but are not limited to:

• Acute Vessel Occlusion
• Air Embolism
• Allergic reaction and anaphylaxis from contrast media
• Arteriovenous fistula
• Death
• Device malfunction
• Distal Embolization
• Emboli
• False Aneurysm Formation
• Hematoma or Hemorrhage at the puncture site
• Inability to completely remove thrombus
• Infection
• Intracranial Hemorrhage
• Ischemia
• Kidney damage from contrast media
• Neurological Deficit including Stroke
• Risks Associated with angiographic and fluoroscopic radiation including but not limited to: Alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia
• Sterile inflammation or granulomas at the access site
• Tissue necrosis
• Vessel Spasm, Thrombosis, Dissection or Perforation

Warning

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.

Warnings

• The AXS Vecta Aspiration Catheter has not been evaluated for more than one (1) clot retrieval attempt.
• The AXS Vecta Aspiration Catheter was evaluated for an average duration of direct aspiration of 4 minutes.
• This product is intended for single use only, do not re-sterilize or reuse. Re-sterilization and/or reuse may result in cross contamination and/or reduced performance.
• When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter if resistance is met during manipulation; determine the cause of the resistance before proceeding.
• Operators should take all necessary precautions to limit X-Radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-Ray technical factors where possible.
• This device is coated with a hydrophilic coating at the distal end of the device for a length of 25 cm. Please refer to the Device Preparation Section for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.

Precautions

• Do not use kinked, damaged, or opened devices.
• Use the device prior to the “Use By” date specified on the package.
• Exposure to temperatures above 54°C (130°F) may damage device. Do not autoclave.
• Torqueing or moving the device against resistance may result in damage to the vessel or device.
• Maintain a constant infusion of appropriate flush solution.
• If flow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
• Examine the device to verify functionality and to ensure that its size and shape are suitable for the specific procedure for which it is to be used.
• The AXS Vecta Aspiration System should be used only by physicians trained in percutaneous procedures and/or interventional techniques.
• The Scout Introducer should be used with a guidewire and Microcatheter inserted when in vasculature.
• If using the AXS Vecta Aspiration System for Thrombectomy, monitor the canister fluid level and replace the canister if the fill level reaches 75% of the canister volume
• Administration of anticoagulants and antiplatelets should be suspended until 24 hours post-treatment. Medical management and acute post stroke care should follow the ASA guidelines.
• Any neurological determination should be evaluated by urgent CT scan and other evaluations as indicated according to investigator/hospital best practice.
• As in all surgical interventions, monitoring of intra-procedural blood loss is recommended so that appropriate management may be instituted.
• Limit the usage of the AXS Vecta Aspiration Catheter to arteries greater than the catheter’s outer diameter.
• Excessive aspiration with the distal tip of the AXS Vecta Aspiration Catheter covered by the vessel wall may cause vessel injury. Carefully investigate location of the distal tip under fluoroscopy prior to aspiration.
• There is an inherent risk with the use of angiography and fluoroscopy.
• When transporting the Medela Dominant Flex Pump, utilize the pump handle.

AXS Infinity LS Plus Long Sheath

RX ONLY

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

Indications for use

The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Contraindications

There are no known contraindications.

Potential adverse events

• Acute vessel occlusion
• Air embolism
• Death
• Distal embolization
• Emboli
• False aneurysm formation
• Hematoma or hemorrhage at the puncture site
• Infection
• Intracranial hemorrhage
• Ischemia
• Neurological deficit including stroke
• Vessel spasm, thrombosis, dissection or perforation

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.

1. Do not re-sterilize or reuse, intended for single use only. Re-sterilization and/or reuse may result in cross contamination and/or reduced performance.
2. When the long sheath is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the long sheath if resistance is met during manipulation; determine the cause of the resistance before proceeding.

Precautions

1. Store in a cool, dry, dark place.
2. Do not use kinked, damaged, or opened devices.
3. Use the device prior to the “Use By” date specified on the package.
4. Exposure to temperatures above 54°C (130°F) may damage device. Do not autoclave.
5. Torquing or moving the device against resistance may result in damage to the vessel or device.
6. Maintain a constant infusion of appropriate flush solution.
7. If flow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
8. Examine the device to verify functionality and to ensure that its size and shape are suitable for the specific procedure for which it is to be used.
9. The AXS Infinity LS Plus Long Sheath should be used only by physicians trained in percutaneous procedures and/or interventional techniques.
10. Do not use if labeling is incomplete or illegible.

Trevo Trak 21 Microcatheter

RX ONLY

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

Intended use/indications for use

The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

Complications

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: death, emboli, hematoma at the puncture site, hemorrhage, ischemia, neurological deficits including stroke, vasospasm, vessel perforation.

Use of device requires fluoroscopy which presents potential risks to physicians and patients associated with x-ray exposure. Possible risks include, but are not limited to, the following: alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, delayed neoplasia.

Compatibility

Refer to product label for device dimensions. Refer to labeling provided with other medical technologies to determine compatibility.

Minimum recommended guide catheter inner diameter: 0.058in (1.47mm)

Maximum recommended guide wire outer diameter: 0.018in (0.46mm)

Warnings

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

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

• 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.
• Upon removal from package, inspect device to ensure it is not damaged.
• Do not expose device to organic 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.
• Torquing the catheter may cause damage which could result in kinking or separation of the catheter shaft.
• Operators should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible.