FDA recommends approval of stenting to prevent stroke

Apr 21 2004

The Cordis Carotid System, intended for treatment as a minimally invasive alternative to carotid endarterectomy (surgical removal of arterial plaque) in high-risk patients, is the first system of its kind to be recommended for FDA approval.

Conditions for approval recommended by the review panel include a clarification of eligible patients, postmarket patient review and appropriate use of the system's distal protection device to minimize the risk of stroke.

"We are pleased to receive the Review Panel's recommendation for our Cordis Carotid System," said Guy Lebeau, M.D., a Johnson & Johnson company group chairman with worldwide management responsibility for Cordis Corporation. "This is an important step toward reaching our goal of providing a safe, effective treatment alternative to patients with carotid artery narrowing and at high risk for surgical treatment."

Carotid artery disease – a buildup of atherosclerotic plaque (fatty material) in major vessels of the neck that supply blood to the brain – is an important risk factor for stroke. Stroke is the nation's third leading cause of death and a major cause of serious, long-term disability.

The Cordis Carotid System, currently an investigational device in the U.S., includes two components: the PRECISE® Nitinol Self-Expanding Stent and the ANGIOGUARD™ Emboli Capture Guidewire. These products currently are approved for use in carotid arteries outside the U.S.

The Cordis Carotid System is intended to improve blood flow to the brain while helping to prevent debris from entering cerebral circulation. The ANGIOGUARD™ Emboli Capture Guidewire System 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. After the stent is implanted to hold the artery open, the protective basket is closed and removed through the delivery catheter.

The premarket approval application is supported by results of the landmark SAPPHIRE* Study, the first and only multicenter, randomized clinical study comparing the results of carotid artery stent placement with embolic protection to the results of carotid endarterectomy in high-risk surgical patients. The study included 334 patients (167 who received a stent and 167 who were treated surgically) at 29 U.S. treatment centers.

Results showed the Cordis Carotid System to be at least as effective as surgery in restoring carotid artery blood flow, with a lower incidence of associated major adverse events (per Kaplan-Meier analysis 12 percent for stent placement versus 20.1 percent for surgery p=0.048). Post-treatment follow-up revealed rates of serious complications, such as heart attack, stroke and cranial nerve damage, to be lower in patients who received a stent compared with those treated surgically.

For more than 40 years, Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis Corporation the world's leading developer and manufacturer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, 7,000 Cordis Corporation employees worldwide share a strong commitment to continue the company's groundbreaking work in the fight against vascular disease.