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New Device Approval

ACCULINK™ Carotid Stent System
RX ACCULINK™ Carotid Stent System - P040012

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: ACCULINK™ and RX ACCULINK™ Carotid Stent System
Applicant: Guidant Corporation
Address: Mailstop S216, 3200 Lakeside Drive, Santa Clara, CA 95054
Approval Date: August 30, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf4/p040012a.pdf

What is it? This device has two systems: the stent and delivery catheter system (ACCULINK™ and RX ACCULINK™ Carotid Stent System) used with an embolic protection system (ACCUNET™ and RX ACCUNET™ EPS). The stent is a metal mesh tube on a delivery catheter. The embolic protection device is a micromesh filter basket on the end of a delivery catheter that catches any particles that may break off from the blockage during the operation.

How does it work? A Carotid Stent System is inserted during angioplasty, a less invasive procedure in which the stent is threaded up to the neck artery via a catheter inserted in the groin.

• First, the ACCUNET™ or RX ACCUNET™ EPS is inserted into the vessel in the groin and advanced up to the blood vessel in the neck where there is blockage.
• The ACCUNET™ or RX ACCUNET™ EPS is opened up like an umbrella. It has small holes to allow blood to flow through, but small enough to catch any particles that may break off from the blockage during the operation.
• After the ACCUNET™ or RX ACCUNET™ EPS is positioned, the physician uses the same wire to advance the metal stent to the blocked area.
• The metal (nitinol) stent (ACCULINK™ and RX ACCULINK™ Carotid Stent System) is then allowed to come out of the catheter and opens automatically over the blockage.
• The catheter is removed, and another catheter is put up into the neck vessel to close the ACCUNET™ or RX ACCUNET™ EPS and remove it, along with any particles that were trapped.

When is it used? The Carotid Stent Systems are used in patients who:

• have had a transient ischemic attack (TIA) or stroke and have at least 50% blockage in the carotid artery,
• are asymptomatic (no previous TIA or stroke) but have a carotid artery that is at least 80% blocked, and
• have either medical problems or body abnormalities that would cause them not to be good candidates for the surgical alternative (carotid endarterectomy).

What will it accomplish? A clinical study of 581 patients showed that the new stent system successfully opened blockages in 92 percent of patients. When complications from use of the stent were compared to complications reported in the medical literature from patients undergoing surgery, the risk of combined complications of death, stroke and heart attack at 30 days or stroke in the area of the blockage at one year was about 10% compared to 15% for surgery. In addition, the study showed that the stent still allowed blood flow to the brain more than two years after the procedure.

When should it not be used? The Carotid Stent Systems should not be used in patients who:

• cannot take blood thinners;
• have bleeding disorders, such as hemophilia or Von Willebrand’s disease;
• are allergic to nitinol, a nickel-titanium alloy;
• have blockages at the beginning of the neck artery; or
• have problems preventing the catheter from getting to the blockage.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf4/p040012.html

Other:
FDA Talk Paper:
http://www.fda.gov/bbs/topics/news/2004/NEW01111.html

Illustration of the carotid artery:
http://www.nlm.nih.gov/medlineplus/ency/imagepages/9552.htm

Interactive tutorial on preventing strokes:
http://www.nlm.nih.gov/medlineplus/tutorials/preventingstrokes.html

Interactive tutorial on carotid endarterectomy:
http://www.nlm.nih.gov/medlineplus/tutorials/carotidendarterectomy.html

Interactive tutorial on angioplasty:
http://www.nlm.nih.gov/medlineplus/tutorials/coronaryangiographyandangioplasty.html

Updated September 20, 2004

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