What is an Acculink stent?

2.0 INDICATIONS The ACCULINK TM Carotid Stent System, used in conjunction with Guidant carotid embolic protection systems, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy (See Section 7.0 of these instructions) who require carotid revascularization and meet the …

What is a carotid stent made of?

Nitinol is an alloy composed mostly of nickel-titanium as well as cobalt and other metal elements. Nitinol alloy is the material most commonly used in carotid stents nowadays, usually for self-expanding stents. Self-expanding nitinol stents are usually manufactured slightly larger than the size of the target vessel.

Is carotid artery stenting safe?

The National Institute for Health and Care Excellence (NICE) has confirmed stenting is a safe procedure and has good short-term results. Evidence suggests a successful stent procedure has the same long-term risks of a stroke as carotid endarterectomy.

Are carotid stents drug eluting?

Drug eluting stents have shown to attenuate this complication. Currently, no clinical data on drug eluting stents in carotid arteries are available. This article discusses the current literature on carotid artery stenting and the potential role of drug eluting stents in this field.

How do self expanding stents work?

Nitinol stents are manufactured to a size slightly larger than the target vessel size and delivered constrained in a delivery system. After deployment, they position themselves against the vessel wall with a low, “chronic” outward force. They resist outside forces with a significantly higher radial resistive force.

How long does a stent last in a carotid artery?

Once a stent is placed in a carotid artery, the stent permanently stays inside the artery. Once placed, the stent permanently stays inside the artery. There is a 2-3% risk of repeat narrowing if the stent also gets blocked in the future. This usually happens within the first 6-9 months.

How successful are carotid stents?

Procedural success was 100% for stenting and 98% for filter placement/retrieval. Nevertheless, the death and major disability from stroke rate was 4% (two patients).

What are the contraindications for the RX acculink carotid stent?

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.

How do I report adverse events with the acculink’carotid stent system?

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

Will the acculinktm carotid stent migrate in this MRI environment?

The ACCULINKTM Carotid Stent should not migrate in this MRI environment. Non-clinical testing has not been performed to rule out the possibility of stent migration at field strengths higher than 3.0 Tesla or a maximum spatial gradient higher than 3.3 Tesla/meter.

Can I use the acculinkmtcarotid stent system twice?

If a tapered stent is used and a second stent is necessary, the second ACCULINKTM Stent should match the diameter of the adjacent tapered stent. WARNING: The ACCULINKMTCarotid Stent System is contraindicated for use with lesions in the ostium of the common carotid artery.