INDICATIONS, SAFETY, AND WARNINGS MindFrame Capture LP Revascularization Device

INDICATIONS FOR USE

The MindFrame Capture™ LP revascularization device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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. This device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke.


Contraindications

Use of the MindFrame Capture LP revascularization device is contraindicated under these circumstances:

  • Patients with known hypersensitivity to nickel-titanium.
  • Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the MindFrame Capture LP device.
  • Patients with angiographic evidence of carotid dissection.

POTENTIAL COMPLICATIONS

Possible complications include but are not limited to the following:

  • Hematoma and hemorrhage at puncture site
  • Pseudo aneurysm formation
  • Perforation or dissection of the vessel
  • Post procedure bleeding
  • Vascular spasm
  • Distal embolization including to a previously uninvolved territory
  • Change in mental status
  • Adverse reaction to antiplatelet/ anticoagulation agents or contrast media
  • Neurologic deterioration including stroke and death
  • Device(s) deformation, collapse, fracture, or malfunction
  • Ischemia
  • Thrombosis (acute and subacute)
  • Infection
  • Arteriovenous Fistula
  • Air Embolism
  • Intracranial Hemorrhage
  • Vascular occlusion

WARNINGS

  • The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.
  • Do not torque the MindFrame Capture LP device.
  • For Vessel Safety, do not perform more than three recovery attempts in the same vessel using MindFrame Capture LP devices.
  • For Device Safety, do not use each MindFrame Capture LP device for more than two flow restoration recoveries.
  • For each new MindFrame Capture LP device, use a new microcatheter.
  • To prevent device separation:
    • Do not oversize device
    • Do not recover (i.e. pull back) the device when encountering excessive resistance. Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration.
    • Do not treat patients with known stenosis proximal to the thrombus site.