Cordis ANGIOGUARD® RX Emboli Capture Guidewire System

Essential Prescribing Information

Indications

The ANGIOGUARD® RX Emboli Capture Guidewire System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3 mm to 7.5 mm (see Section 9.3 of the full "Instructions for Use" for basket/vessel sizing).

Contraindications

Use of the ANGIOGUARD® RX Guidewire System is contraindicated in the following patients:

  • Patients in whom antiplatelet and or anticoagulation therapy is contraindicated.
  • Patients in whom the guide catheter is unable to be placed.
  • Patients with uncorrected bleeding disorders.
  • Patients with known allergies to nitinol.
  • Lesions in the ostium of the common carotid artery

Warnings

  • Only physicians who have received appropriate training for carotid stenting and who are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device.
  • The safety and efficacy of the ANGIOGUARD® have not been demonstrated with embolic protection systems other than the PRECISE® Stent System.
  • Overstretching of the artery may result in rupture and life-threatening bleeding.
  • Patient ACT of >300 seconds needs to be maintained during ANGIOGUARD® RX Guidewire System deployment.
  • The safety and effectiveness of this device as an emboli protection system has not been established in the coronary, cerebral, or peripheral vasculature, other than carotid arteries.
  • Safety and effectiveness of the angioplasty and carotid stenting procedure has NOT yet been established in patients with the characteristics noted below.
    • Lesion Characteristics:
    • Patients with evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization.
    • Patients whose lesion(s) may require more than two stents.
    • Patients with total occlusion of the target vessel.
    • Patients with lesions of the ostium of the common carotid.
    • Patients with highly calcified lesions resistant to PTA.
    • Concurrent treatment of bilateral lesions.
    • Patient Characteristics:
    • Patients at low-to-moderate risk for adverse events from carotid endarterectomy.
    • Patients experiencing acute ischemic neurologic stroke or who experienced a stroke within 48 hours.
    • Patients with an intracranial mass lesion (i.e., abscess, tumor, or infection) or aneurysm (>9mm).
    • Patients with arterio-venous malformations in the territory of the target carotid artery.
    • Patients with coagulopathies.
    • Patients with poor renal function, who, in the physician’s opinion, may be at high risk for a reaction to contrast medium.
    • Patients with perforated vessels evidenced by extravasations of contrast media.
    • Patients with aneurysmal dilation immediately proximal or distal to the lesion.
    • Pregnant patients or patients under the age of 18.
    • Access Characteristics:
    • Patients with known peripheral vascular, supra-aortic or internal carotid artery tortuosity that would preclude the use of catheter-based techniques.
    • Patients in whom femoral or brachial access is not possible.
  • Risk of distal embolization may be higher if the Cordis ANGIOGUARD® RX Guidewire System is not used during carotid stenting procedures.
  • This device is intended for one-time use only. Do not resterilize and/or reuse.
  • Observe all guidewire movement in the vessels using fluoroscopic guidance.
  • DO NOT TORQUE THE GUIDEWIRE.
    • Do not torque a guidewire without observing corresponding movement of the tip; otherwise, vessel trauma could occur.
    • Torquing a guidewire against resistance may cause guidewire damage and/or guidewire tip separation. Always advance or withdraw the guidewire slowly. Never push, auger, withdraw or torque a guidewire that meets resistance.
  • Before the guidewire is moved, tip movement should be examined using fluoroscopy.
  • Perform all exchanges slowly to prevent air from entering the catheter system.
  • When introducing the guidewire, confirm that the guiding catheter or interventional sheath introducer tip is free within the vessel lumen and not against the vessel wall Failure to do so may result in vessel trauma upon guidewire exit from the tip. Use the radiopaque marker of the interventional device to confirm position.

Precautions

  • Confirm the compatibility of the ANGIOGUARD® RX Guidewire System with the rapid exchange interventional device before actual use.
  • If distal perfusion of dye is significantly reduced or no dye is perfusing past the distal marker band of the filter basket, the ANGIOGUARD® RX Guidewire System may have reached its maximum capacity to contain emboli. Remove and replace with a new ANGIOGUARD® RX Guidewire System.
  • Do not attempt to close the filter basket with the Deployment Sheath. The ANGIOGUARD® RX Guidewire System should only be removed using the Capture Sheath.
  • Care during diagnostic or interventional device exchanges must be practiced to minimize movement of the guidewire/filter basket.
  • Use caution when withdrawing the ANGIOGUARD® RX Emboli Capture Guidewire through the deployed stent.

Adverse Events

Adverse events that may be associated with the use of the ANGIOGUARD® RX Guidewire System in carotid artery stenting procedures, include, but may not be limited to:

  • Air embolism
  • Allergic/anaphylactoid reaction
  • Aneurysm
  • Angina/coronary ischemia
  • Arrhythmia (including bradycardia, possibly requiring need for a temporary or permanent pacemaker)
  • Arterial occlusion/vessel restenosis
  • Arterial occlusion/thrombus at and remote from puncture site
  • Arteriovenous fistula
  • Bacteremia or septicemia
  • Cerebral edema
  • Damage to emboli capture device
  • Death
  • Embolization (stent or arterial)
  • Emergent repeat hospital intervention
  • Fever
  • GI bleeding from anticoagulation/antiplatelet medication
  • Hematoma bleed (puncture or remote site)
  • Hemorrhage
  • Hyperperfusion syndrome
  • Hypotension/hypertension
  • Infection
  • Intimal injury/dissection
  • Ischemia/infarction of tissue/organ
  • Local infection/pain at insertion site
  • Malposition (failure to deliver stent to the intended site)
  • Myocardial infarction
  • Pain
  • Pseudoanuerysm
  • Renal failure
  • Restenosis of the vessel (= 50% obstructional)
  • Seizure
  • Severe unilateral headache
  • Stent migration
  • Stent thrombosis
  • Stroke
  • Transient Ischemic Attack
  • Vasospasm
  • Venous occlusion/thrombosis at and remote from puncture site
  • Vessel rupture, dissection, perforation

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
See package insert for full product information.