Cordis Carotid System for Carotid Artery Disease

admin — Wed, 21 Apr 2004 17:52:17 +0000

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

CYPHER Sirolimus-eluting Stent

admin — Fri, 20 Feb 2004 20:49:04 +0000

On February 18, 2004, Cordis Corporation announced completion of patient enrollment in the first randomized head-to-head coronary stent trial comparing its new CYPHER sirolimus-eluting coronary stent with the Taxus Express (2) paclitaxel-eluting coronary stent. This trial is expressly designed to compare performance differences between the two drug-eluting stents, particularly in high-risk patient group subsets such as diabetics and patients with long lesions and small-diameter vessels. The CYPHER stent is currently the only FDA approved drug-eluting stent available for use in the United States. Boston Scientific’s Taxus paclitaxel-eluting stent has yet to receive approval from the FDA. Unlike traditional or ‘bare metal’ stents, the CYPHER stent is coated with a naturally occurring substance named sirolimus and a unique polymer. The stent props the blocked coronary artery open while the polymer gradually releases the sirolimus into the vessel wall to stop the growth of scar tissue, which causes restenosis. The pivotal Cordis-sponsored Sirius Clinical Trial involving 1,058 patients demonstrated as much as a 91% reduction in in-stent restenosis, and a 75% reduction in target lesion revascularization versus the control arm. Sirolimus is a cytostatic agent, meaning it stops cells from dividing without destroying them. It is an anti-rejection medication first used in kidney transplant patients.

In excess of five million Americans are treated for coronary artery disease each year. Most of these patients (about 80%) are treated medically, however, in excess of 1million patients will require more invasive procedures like Coronary Artery Bypass Grafting (CABG) or angioplasty. Among those patients receiving stents, 15-20% will require repeat treatment for restenosis. The CYPHER stent, approved for U.S. marketing in April 2003, has been used to treat approximately 500,000 patients in more than 80 countries worldwide. Industry analysts value the drug-eluting stent market in the 3-4 billion dollar per annum range. The actual direct cost increase associated with CYPHER compared to a bare metal stent is significant. Each CYPHER stent costs in the $2500 to $3000 range. This represents an increase of 200-300% over the per unit costs of a bare metal stent. It is duly noted that the significant decrease in restenosis rates and therefore revascularization procedures may ultimately reduce the cost per patient treated by a given health services organization.

The CYPHER stent is currently in our High Impact Technology category. All clients with significant cath-lab operations should commence or continue assessment activities as soon as possible.

Technology Details
Target Disease / Indication: Coronary Artery Disease
Technology Classification: Combination Drug/Device
Body System: Cardiovascular System
Program Area: Medicine/Cardiology
Regulatory Status: Approved
BioHorizon Impact Score: 86/100 – High

BioHorizon » Cordis

Cordis Carotid System for Carotid Artery Disease

CYPHER Sirolimus-eluting Stent