RX Acculink Carotid Stent System (U.S)

Features

Optimal Design

• Conformable stents crafted with self-expanding, crush-resistant nitinol
• High-coverage stents designed to reduce embolic risk
• Complete set of stent sizes for optimal carotid stent treatment
• 30-40 mm tapered lengths to fit individual patient anatomies

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Low Profile
Highly deliverable .014" low-profile system

• 6F sheath/8F guiding catheter compatible
• Compatible with 100 cm guiding catheters and sheaths

Nominal Shortening

• Nominal stent shortening aids in accurate stent placement
• 1.0% on the 7.0 x 40 mm stent¹

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Excellent Accuracy

• Controlled placement — three longitudinal spines reduce stent shortening
• Handle-based delivery system for accurate stent placement

see larger image ACCULINK Carotid Stent System

Easy to Use

• The simple-to-use rapid exchange design allows accuracy and control
• Simple, straightforward device exchanges
• Rapid exchange platform allows one physician operator to control procedure
• Unique handle allows accurate single-handed deployment while retracting sheath

_{1. Testing performed by and data on file at Guidant.}

Specifications

RX ACCULINK Carotid Stent System Product Specifications 147 KB

Indications and Important Safety Information

RX Acculink® Carotid Stent System

INDICATIONS

The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunetembolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below.

1.   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, AND

2.   Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. 

CONTRAINDICATIONS

The RX Acculink Carotid Stent System is contraindicated for use in:

•     Patients in whom anti-coagulant and / or anti-platelet therapy is contraindicated. 

•     Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system, or stent system.

•     Patients with known hypersensitivity to nickel-titanium.

•     Patients with uncorrected bleeding disorders.

•     Lesions in the ostium of the common carotid artery.

WARNINGS

General

Refer to the Instructions for Use supplied with any interventional devices to be used in conjunction with the RX Acculink Carotid Stent System for their intended uses, contraindications, and potential complications.

The safety and efficacy of the RX Acculink Carotid Stent System have not been demonstrated with embolic protection systems other than the Abbott Vascular RX Accunetembolic protection system.

The long-term performance (> 3 years) of the Acculink Carotid Stent 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.

PRECAUTIONS

Stent Handling - Precautions

Carefully inspect the RX Acculink Carotid Stent System to verify that the device has not been damaged in shipment.  Do not use damaged equipment.

The delivery system has an internal hypotube.  Take care to avoid unnecessary handling, which may kink or damage the delivery system.  Do not use if device is kinked.

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

Do not remove the stent from its delivery system as removal may damage the stent. The stent on the delivery system is intended to perform as a system.  If removed, the stent cannot be put back on the delivery system.

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

Special care must be taken not to handle or in any way disrupt the stent on the delivery system. This is most important during catheter removal from packaging, mandrel removal, placement over the guide wire, and advancement through a Rotating Hemostatic Valve (RHV) adapter and guiding catheter hub.

Do not hold the sheath or stent during mandrel removal.

Stent Placement - Precautions

Use with bleedback control hemostatic valves is not recommended.

The RX Acculink System is not compatible with any guide wire larger than 0.014” (0.36 mm).

Leave the safety lock closed until the stent is ready to deploy.

The RX Acculink Carotid Stent System must be used with a guiding catheter or introducer sheath to maintain adequate support of the 0.014” guide wire throughout the procedure.

For best device performance, the guide wire exit notch should remain within the guiding catheter or sheath.

Ensure the stent system is fully flushed with heparinized saline prior to use.  Do not use the delivery system if flush is not observed exiting at the distal end of the sheath.

Do not attempt to pull a partially expanded stent back through the guiding catheter or sheath; dislodgment of the stent from the delivery system may occur.

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

When catheters are in the body, they should be manipulated only under fluoroscopy.  Radiographic equipment that provides high quality images is needed.

The delivery system is not designed for use with 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 delivery system.

When 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.  Stenting in this order obviates the need to cross the proximal stent for placement of the distal stent and reduces the chance of dislodging stents that have already been placed.

If overlap of sequential stents is necessary, the amount of overlap should be kept to a minimum (approximately 5 mm).  In no instance should more than 2 stents overlap.

Post-Implant - Precautions

Care must be exercised when crossing a newly deployed stent with other interventional devices to avoid disrupting the stent geometry and placement of the stent.

In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.

Potential Adverse Events

Based on the literature, and on clinical and commercial experience with carotid stents and embolic protection systems, the following alphabetical list includes possible adverse events associated with use of these devices;

•     Allergic reactions to anti-platelet 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

•     Hyperperfusion syndrome

•     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 segment

•     Seizure

•     Severe unilateral headache

•     Stent / filter entanglement / damage

•     Stent embolization

•     Stent malposition

•     Stent migration

•     Stent thrombosis / occlusion

•     Stroke / cerebrovascular accident (CVA)

•     Total occlusion of carotid artery

•     Vessel dissection, perforation, or rupture

•     Vessel spasm or recoil

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

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