NeVasc Instructions for Use

Indications, Safety, and Warnings

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

Indication for Use

The NeVasc Aspiration Catheter, with the Vesalio Aspiration Tubing Set and a compatible suction pump is indicated for use 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

Aspiration tubing:
The Vesalio Aspiration Tubing Set is intended to connect the NeVasc Aspiration Catheter to a compatible aspiration pump.

CONTRAINDICATIONS

There are no known contraindications.

Warnings

    • The NeVasc Aspiration System should only be used by physicians who have received appropriate training in interventional techniques.
    • The NeVasc Aspiration System has not been evaluated for combined use with stent-retrievers.
    • Do not use the NeVasc Aspiration Catheter in vessels with an inner diameter smaller than the outer diameter (OD) of the catheter. Use in inadequately sized vessels may lead to vessel injury, including rupture, intracranial hemorrhage (ICH), or death.
    • The safety and effectiveness of mechanical neurothrombectomy devices has only been evaluated via transfemoral access.
    • The device is intended for single use only. Do not reuse or re-sterilize. Discard the catheter after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning. Catheters are extremely difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused.
    • Verify that the aspiration pump meets the predefined specification before use, do not exceed maximum vacuum setting of 26.5 inHg.
    • The NeVasc Aspiration System has not been tested for use with automated high-pressure contrast injection equipment, do not use this equipment with the device as it may damage the device.
    • This device is coated with a hydrophilic coating at the distal end. Refer to the Instructions for Use 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.
    • The NeVasc Aspiration Catheter has been verified for use with an aspiration pump. When choosing an aspiration pump, carefully review the aspiration pump performance parameters to ensure it can achieve operating vacuum pressures between -20 inHg and -28 inHg and minimum flow rate of 17 L/min.

Precautions

  • Do not use kinked or damaged devices.
  • Do not use open or damaged packages.
  • Do not use if sterile packaging of the device is opened or damaged before its usage.
  • Use prior to the “Use by date”.
  • Do not autoclave.
  • Use the NeVasc Catheter in conjunction with fluoroscopic visualization.
  • Inspect each catheter before use to verify that its size and condition are suitable for the specific procedure.
  • Manually flush catheter prior to insertion.
  • Do not advance or withdraw the catheter against resistance without careful assessment of the cause using fluoroscopy. If the resistance cause cannot be determined exercise caution when removing the device and/or other components as a unit, and exchange the device for a new one to complete the procedure.
  • Moving or torquing 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 catheter becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
  • Extreme care must be taken to avoid damage to the vasculature through which the catheters pass.
  • The catheters may occlude smaller vessels. Care must be taken to avoid complete blood flow blockage.
  • Torquing the catheters may cause damage which could result in kinking and possible separation along the catheter shaft or may compromise the coating integrity that may not always be noticeable to the naked eye. Should the system become severely kinked, withdraw the entire system (NeVasc Catheter, guide wire, guide catheter, and/or sheath).
  • Avoid wiping the device with dry gauze as this may damage the device coating.
  • Avoid excessive wiping of the distal segment containing hydrophilic coating.
  • Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could affect the device safety and performance.
  • Ensure that the device is hydrated as stated in these instructions for use to avoid any potential impact to the coating performance.
  • Limit the exposure of X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.
  • Avoid pre-soaking devices for more than two (2) hours when the device is not in use, as this may impact coating safety and performance. Hydrophilic coating may swell when exposed to aqueous media for more than two (2) hours resulting in a tight fit of introduced devices.
  • Use caution when manipulating, advancing and/or withdrawing the device through needles, metal cannulas, stents, or other devices with sharp edges, or through tortuous or calcified blood vessels. Manipulation, advancement, and/or withdrawal past sharp or bevelled edges may result in destruction and/or separation of the coating, resulting in coating material remaining in the vasculature or device damage, which may lead to clinical adverse events requiring additional intervention.

Risks and Undesirable Side Effects

Possible complications include, but are not limited to, the following:

  • acute occlusion
  • air embolism
  • allergic reaction and anaphylaxis from contrast media
  • arteriovenous fistula
  • embolic stroke
  • false aneurysm formation
  • hematoma or hemorrhage
  • inability to completely remove thrombus
  • increased procedure time
  • infection
  • inflammatory responses
  • intracranial hemorrhage
  • ischemia
  • kidney damage from contrast media
  • Myocardial embolism
  • neurological deficits including stroke
  • Cerebral infarct
  • death
  • device malfunction
  • distal embolization
  • Pulmonary embolism
  • Pulmonary infarct
  • Surgical intervention
  • Sterile inflammation or granulomas at the access site
  • Tissue necrosis, transient, or long-lasting
  • vessel spasm, thrombosis, dissection, rupture or perforation
  • radiation exposure that may lead to cataracts, skin reddening, or burns from x-ray exposure