XACT™ Carotid Stent System

INDICATIONS

The XACT™ Carotid Stent System (XACT™), used in conjunction with the Emboshield™ family of Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the criteria outlined below:

Patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or ≥ 80% for asymptomatic patients by ultrasound or angiography), located between the origin of the common carotid artery and the intra-cranial segment of the internal carotid artery AND

Patients must have a reference vessel diameter ranging between 4.8 mm and 9.1 mm at the target lesion.

CONTRAINDICATIONS

Contraindications associated with angioplasty must be considered when using the XACT™ Carotid Stent System. These include, but are not limited to:

• Patients in whom anticoagulant and / or antiplatelet therapy is contraindicated.
• Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of the Guiding Catheter / Introducer Sheath, BareWire™ guide wire, Emboshield™ Delivery Catheter, Filtration Element, and / or Retrieval Catheter.
• Patients with a known hypersensitivity to nickel-titanium.
• Patients with uncorrected bleeding disorders.
• Lesions in the ostium of the common carotid artery.

WARNINGS

General

Refer to instructions supplied with all interventional devices to be used with the XACT™ Carotid Stent System for their intended uses, contraindications, and potential complications.

The safety and efficacy of the XACT™ Carotid Stent System has not been demonstrated with embolic protection systems other than the Emboshield™ Embolic Protection System.

The long-term performance (> 1 year) of the XACT™ Carotid Stent System has not been established.

As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm, or rupture.

Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures.

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.

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.

When multiple stents are required, stent materials should be of similar composition.

The safety and effectiveness of the XACT™ Carotid Stent System has NOT yet been established in patients with the characteristics noted below.

• Low to moderate risk for adverse events from carotid endarterectomy
• Previously placed stent in target artery.
• Total occlusion of target lesion.
• Angiographically visible thrombus.
• Carotid string sign (a tiny, long segment of contrast in the true lumen of the artery).
• Vessel anatomy precluding the use of the stent system or appropriate positioning of the embolic protection system.
• Presence of carotid artery dissection prior to initiation of the procedure.
• Evidence of a stroke within the previous 30 days.
• History of ipsilateral stroke with fluctuating neurologic symptoms within 1 year.
• History of intracranial hemorrhage within the past 3 months.
• Any condition that precluded proper angiographic assessment or made percutaneous arterial access unsafe, (e.g. morbid obesity, sustained systolic blood pressure > 180 mmHg).
• Contraindication to aspirin, or to clopidogrel AND ticlopidine, or stent material.
• History or current indication of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an activated clot time at > 250 seconds.
• Hemoglobin (Hgb) < 8 gm / dl (unless on dialysis), platelet count < 50,000, INR > 1.5 (irreversible), or heparin-associated thrombocytopenia.
• Known cardiac sources of emboli.
• Atherosclerotic disease involving adjoining vessels precluding safe placement of the guiding catheter or sheath.
• Other abnormal angiographic findings that indicated the patient was at risk of a stroke due to a problem other than that of the target lesion, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature.
• Severe dementia.
• Life threatening allergy to contrast media that could not be treated.
• Pregnant patients or patients under the age of 18.
• Patients in whom femoral access is not possible.
• Patients with aneurysmal dilation immediately proximal or distal to the lesion.

The safety and effectiveness of concurrent treatment of lesions in patients with bilateral carotid artery disease have not been established.

PRECAUTIONS

Carefully inspect device components prior to use to verify that they have not been damaged and that the size, shape and condition are suitable for the procedure for which they are to be used. A device or access device which is kinked or damaged in any way should not be used. If pouch is damaged do not use.

Confirm the compatibility of the XACT™ Stent Delivery System with the interventional devices before actual use.

Precautions to prevent or reduce clotting should be taken when any interventional device is used. Flush or rinse all devices entering the vascular system with sterile isotonic heparinized saline prior to use.

Do not remove the stent from its delivery system as removal may damage the stent. The stent and delivery system are intended to be used in tandem. If removed, the stent cannot be put back on the delivery system.

The delivery system should not be used in conjunction with other stents.

To reduce the potential for the liberation of emboli during lesion crossing, the device should be carefully manipulated and not advanced against resistance.

During stent placement, 1.5 cm of vessel should be left between the distal margin of the stent and the Filtration Element. The stent delivery system should not contact the Filtration Element.

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 device must only be flushed using the 3-ml syringe and flushing tip provided.

The outside diameter of the Outer Sheath is 5.7 Fr. An appropriate sized sheath / guiding catheter should be selected based on this diameter.

Do not use a prepared XACT™ Carotid Stent System if the stent is not fully constrained within the Delivery System.

Do not use if the stent is partially deployed.

If, after preparation, a gap between the catheter tip and the outer sheath exists, rotate the Deployment Actuator in an anti-clockwise direction until the gap is closed.

Advancement and deployment of the XACT™ Carotid Stent System should only be performed under fluoroscopic observation.

Do not advance any component, or section thereof, of the XACT™ Carotid Stent System against significant resistance. The cause of any resistance should be determined via fluoroscopy and remedial action taken.

Do not attempt to reposition the Delivery System once the stent has made contact with the vessel wall.

Do not torque the XACT™ Carotid Stent System.

If more than one stent is required to cover the lesion, or if there are multiple lesions, the distal lesion should be stented first, followed by stenting of the proximal lesion.

If overlap of sequential stents is necessary, the amount of overlap should be kept to a minimum.

MRI Information

Non-clinical testing has demonstrated that the XACT™ Carotid Stent is MR Conditional. It can be scanned safely under the conditions listed in the Instructions for Use.

Potential Adverse Effects

As reported in the literature, the following adverse events are potentially associated with carotid stents and embolic protection systems:

• Abrupt closure
• Allergic reactions
• Aneurysm
• Angina/Coronary ischemia
• Arteriovenous Fistula
• Bacteremia or septicemia
• Bleeding from anticoagulant or antiplatelet medications
• Bradycardia/arrhythmia
• Cerebral edema
• Cerebral hemorrhage
• Congestive Heart Failure
• Death
• Drug reactions
• Embolism (including air and device)
• Emergent or urgent Endarterectomy
• Fever
• Filter thrombosis / occlusion
• Fluid overload
• Groin hematoma, with or without surgical repair
• Hemorrhage or hematoma
• Hemorrhagic stroke
• Headache
• Hypotension
• Hyperperfusion syndrome
• Hypertension
• Infection / sepsis
• Ischemia / infarction of tissue / organ
• Myocardial Infarction
• Other conduction disturbances
• Pain and tenderness
• Pain, infection, or discomfort at the access site
• Pseudoaneurysm
• Renal failure / insufficiency
• Restenosis of the stented artery
• Seizure
• Stent deformation, collapse, fracture, movement of stent, possibly requiring emergency surgery
• Stent / filter entanglement / damage
• Stroke or other neurological complications
• Thromboembolic episodes
• Thrombophlebitis
• Total occlusion of the artery
• Transient ischemic attacks (TIAs)
• Vascular access complications (e.g. loss of pulse, femoral artery pseudoaneurysm and infection)
• Ventricular fibrillation
• Vessel dissection, rupture, or perforation
• Vessel thrombosis (partial blockage)
• Unstable angina pectoris