Cordis Carotid System for Carotid Artery Disease

On April 21, 2004 Cordis Corporation announced that the FDA’s Circulatory System Devices Panel had recommended approval of the Cordis Carotid System. Cordis’ pre-market approval application drew upon results of the SAPPHIRE Study, which included 334 high-risk surgical patients randomized to receive the stent with embolic protection vs. the traditional carotid endarterectomy. According to Cordis, the results showed the Carotid System to be as effective as surgery in restoring carotid artery blood flow. Also, a lower incidence of associated major adverse events was noted with the Carotid System. Post-treatment follow-up rates of serious complications such as heart attack, stroke, and cranial nerve damage were lower in patients who received a stent compared with those treated surgically. The FDA panel specified some conditions for approval including: a clarification of eligible patients, a post-market patient review, and the use of the system’s distal protection device to reduce the risk of stroke.

The Cordis Carotid System is comprised of the Precise® Nitinol Self-Expanding Stent and the Angioguard™ Emboli Capture Guidewire. These products are currently approved outside the U.S for use in carotid arteries. The Angioguard is delivered beyond the lesion, where it opens into a tiny perforated basket designed to catch plaque particles dislodged during the angioplasty and stent procedure, while allowing continuous blood flow. Once the stent is implanted to hold the artery open, the protective basket is closed and removed. Cordis has positioned its Carotid System as a minimally invasive alternative to carotid endarterectomy in high-risk patients with carotid artery disease.

Carotid artery disease refers to a buildup of atherosclerotic plaque (fatty material) in the neck’s carotid arteries that supply blood to the brain. In some patients, pieces of this plaque may break off or embolize and cause a stroke. According to CDC surveillance data, stroke is the third leading cause of death in the U.S after heart disease and cancer. Some estimates place the number of carotid endarterectomies performed annually in the U.S in the 100,000 range.

Clients with significant CVT surgery exposure should review carotid endarterectomy volume. Some preliminary clinical epidemiology detailing numbers of procedures on high risk patients is suggested at this time. Biohorizon recommends consultation with CVT surgeons concerning plans for device use if final FDA approval is obtained.

Technology Details
Target Disease / Indication: Carotid Artery Disease
Technology Classification: Device
Body System: Cardiovascular System
Program Area: Surgery/CVT Surgery
Regulatory Status: Investigational
BioHorizon Impact Score: 45/100 – Moderate