RX Accunet^® Embolic Protection Device

INDICATIONS

The RX Accunet EPS is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diamete of the artery at the site of filter basket placement should be between 3.25 mm and 7.0mm.

CONTRAINDICATIONS

The RX Accunet EPS is contraindicated for use in:

• Patients in whom anticoagulent and / or antiplatelet therapy is contraindicated.
• Patients with sever vascular tortuosity or anatomy that would preclude the safe introduction of a guiding catheter, sheath, embolic protection system, or stent system.
• Patients with known hypersensitivity to nickel-titanium.
• Patients with uncorrected bleeding disorders.

WARNINGS

Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device.

General

Refer to the instructions supplied with all inteventional devices to be used in conjunction with the RX Accunet EPS for their intended uses, contraindications, and potential complications.

The safety and effectiveness of this device as an embolic protection system have not been established in vasculatures outside the carotid arteries.

The safety and efficacy of the RX accunet EPS have not been demonstrated with carotid stent systems other than the over-the-wire or RX Acculink Carotid Stent System.

The appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure as suggested in these instructions. Special consideration should be given to those patients with recently active gastritis or peptic ulcer disease.

PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in verssel damage and / or inaccurate torque response.

Do not expose the delivery or recovery systems to organic solvents (e.g. alcohol) as structural integrity and / or function of the device may be impaired.

Confirm the compatibility of the RX Accunet EPS with the interventional devices before actual use.

To avoid air entrapment, do not leave the introducer tool in the valve while advancing the delivery system. Advance the delivery system slowly through the guiding catheter / sheath.

Ensure that the torque device is secured thightly to the guide wire to avoid difficulties with deployment. If the torque device is not tightened securely on the guide wire proper deployment may not occur.

For proper positioning of the filter basket, the vessel distal to the lesion should have an absence of excessive tortuosity and be of adequate length (approximately 4 cm distal to the lesion and proximal to the petrous portion of the vessel).

Reconfirm the filter basket position prior to deployment of the stent to ensure that there is adequate distance between the radiopaque proximal bushing marker on the guide wire with filter basket and the distal end of the desired stent position. Reposition the filter basket as necessary by gently advancing the guide wire. Under fluoroscopy, observe movement of the filter basket to the desired position. Observe all guide wire movement in the vessels using fluoroscopic guidance.

Venous access should be available during carotid stenting in order to manage bradycardia and / or hypotension by either pharmaceutical intervention or placement of a temporary pacemaker, if needed.

The delivery system is not designed for use with power injection. Use of power injection may adversely affect device performance.

Do NOT deliver the RX Accunete EPS guide wire with filter basket through any interventional devices other than the RX Accunet EPS delivery sheath.

Removeal of the RX Accunet EPS guide qire with filter basket through any interventional devices other than the RX Accunet and RX Accunet 2 Recovery Catheters has not been tested.

Care must be used when removing the filter basket through a newly deployed stent to maintain filter basket integrity and to avoid disrupting the stent geometry.

If the RX Accunet EPS is desired for intervention in additional vessels, use a new device.

Potential Adverse Events

Based on the literature, and on clinical and commercial experience with the use of embolic protection systems with a carotid stent, the following alphabetical list includes possible adverse events associated with the use of this device:

• Allergic reactions to antiplatelet agents / contrast medium
• Aneurysm
• Angina / coronary ischemia
• Arrhythmia
• Arterial occlusion / thrombosis at puncture site or remote site
• Arteriovenous fistula
• Bacteremia or septicemia
• Bleeding from anticoagulant or antiplatelet medications
• Cerebral edema
• Cerebral hemorrhage
• Cerebral ischemia / transient ischemic attack (TIA)
• Congestive heart failure (CHF)
• Death
• Detachment and / or implantation of a component of the system
• Emboli, distal (air, tissue, or thrombotic emboli)
• Emergent or urgent endarterectomy surgery (CEA)
• Fever
• Filter thrombosis / occlusion
• Groin hematoma, with or without surgical repair
• Hemorrhage, with or without transfusion
• Hypotension / hypertension
• Infection and pain at insertion site
• Ischemia / infarction of tissue / organ
• Myocardial infarction (MI)
• Pain (head, neck)
• Pseudoaneurysm, femoral
• Renal failure / insufficiency
• Restenosis of stented / dilated vessel
• Seizure
• Severe unilateral headache
• Stent / filter entanglement / damage
• Stroke / cerebrovascular accident (CVA)
• Total occlusion of carotid artery
• Vessel dissection, perforation, or rupture
• Vessel spasm or recoil

Any adverse event occurring involving the RX Accunet EPS should be reported immediately to Abbott Vascular, Customer Service, at (800) 227-9902. If outside the USA, call (951) 914-4669.