PRECISE PRO RX® Carotid Stent System

Indications

The Cordis PRECISE PRO RX® Carotid Stent System, used in conjunction with the Cordis ANGIOGUARD® RX Emboli Capture Guidewire System, is indicated for treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria:

• Patients with neurological symptoms and > 50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and > 80% stenosis of the common or internal carotid artery by ultrasound or angiogram.
• Patients must have a vessel diameter of 4-9mm at the target lesion. The vessel distal to the target lesion must be within the range of 3mm and 7.5mm to allow for placement of the ANGIOGUARD® RX Guidewire System.

Contraindications

• 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 PRECISE® Stent System have not been demonstrated with embolic protection systems other than the ANGIOGUARD® RX Guidewire System. The long-term performance (>3 years) of carotid stents has not yet been established.
• As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm or rupture.
• The stent may cause a thrombus, distal embolization or may migrate from the site of implant down the arterial lumen. Appropriate sizing of the stent to the vessel is required to reduce the possibility of stent migration. In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
• Overstretching of the artery may result in rupture and life-threatening bleeding.
• In patients requiring the use of antacids and/or H2-antagonists before or immediately after stent placement, oral absorption of antiplatelet agents (e.g. aspirin) may be adversely affected.
• Appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure.
• In the event of complications such as infection, pseudoaneurysm or fistulization, surgical removal of the stent may be required.
• Safety and effectiveness of the Cordis PRECISE PRO RX® Carotid Stent System 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 extravasation 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 PRECISE PRO RX® Carotid Stent System device cannot be used in conjunction with the ANGIOGUARD® RX Guidewire System during the carotid stenting procedure.
• The black dotted pattern on the gray temperature exposure indicator found on the pouch must be clearly visible. Do not use if entire circle is completely black as the preprogrammed stent diameter may have been compromised.
• Do not use the device if there are abnormalities in the sterile barrier (e.g. broken seal, torn or breached barrier) or product.
• Do not reuse.
• Do not use with Ethiodol™ or Lipiodol™ contrast media, which may adversely affect the stent delivery system.
• Do not expose the delivery system to organic solvents (e.g. alcohol) as structural integrity and/or function of the device may be impaired.
• The stent is not designed for dragging or repositioning.
• Once the stent is partially deployed, it cannot be recaptured using the stent delivery system.
• As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudo aneurysm or rupture.

Precautions

• Venous access should be available during carotid stenting in order to manage bradycardia and/or hypotension by pharmaceutical intervention or placement of a temporary pacemaker.
• Catheters in the body should be manipulated only under fluoroscopy. Radiographic equipment that provides high quality images is needed.
• The delivery system is not designed for the use of power injection. Use of power injection may adversely affect device performance.
• If resistance is met during delivery system introduction, the system should be withdrawn and another system used.
• Prior to stent deployment, remove all slack from the catheter delivery system.
• When treating multiple lesions, the distal lesion should be initially stented, followed by the proximal lesion. Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent, reducing the chance for dislodging stents that have already been placed.
• Overlap of sequential stents is necessary, but the amount of overlap should be kept to a minimum (approximately 5mm). In no instance should more than 2 stents overlap.
• Recrossing a deployed stent with adjunct devices must be performed with caution.
• In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
• Fractures of this stent may occur. Fractures may also occur with the use of multiple overlapping stents. In the PRECISE Stent, they have been reported most often in clinical uses for which the safety and effectiveness have not been established. The causes and clinical implications of stent fractures are not well characterized. Care should also be taken when deploying the stent as excessive force could, in rare instances, lead to stent deformation and/or fracture.
• The Cordis PRECISE Stent was evaluated through bench testing and has been shown to be MR safe at field strengths of 1.5 Tesla or less, with a maximum spatial gradient of 3 T/m, gradient magnetic fields of 33 mT/m or less, a temporal magnetic field gradient (dB/dt) of 80 T/m/s, and a maximum whole body averaged specific absorption rate (SAR) of 1.33 W/kg for 16:40:00 min of MR imaging. MR imaging quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the PRECISE Stent. The PRECISE Stent has not been evaluated to determine if it is safe in MRI systems with field strengths greater than 1.5 Tesla.

Potential Adverse Events

Possible adverse events include, but are not 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

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