Rapid exchange (RX) versions of carotid artery stents (CAS) are quickly becoming an important niche in the CAS market, saving physicians time during procures and requiring only one operator. And the latest company to receive FDA approval to market such a device is Cordis (Miami Lakes, Florida).

The Cordis Endovascular Division of Cordis last week reported FDA approval to market its Precise RX Nitinol Self-Expanding Stent and Angioguard RX Emboli Capture Guidewire System to treat clogged neck arteries.

Dennis Donohoe, MD, VP of worldwide clinical and medical affairs for Cordis, told Medical Device Daily that the Precise RX Nitinol Self-Expanding Stent and Angioguard RX Emboli Capture Guidewire System are different from Cordis' over-the-wire carotid system approved last year. The RX version only requires one physician operator because it is a shorter wire and the procedure time is also shorter, he said.

"Most physicians prefer the RX version because of the shorter length wire and because it does not require another physician," Donohoe said.

Once inside the patient, the device works the same as the company's over-the-wire version and offers the same clinical results, he said.

Carotid arteries are the main blood vessels leading to the brain. The Precise RX Nitinol Self-Expanding Stent and Angioguard RX Emboli Capture Guidewire System are approved to treat carotid artery disease in patients at high risk for adverse events from carotid endarterectomy (CEA) — a surgical treatment for removing arterial plaque from the carotid artery and associated with increased risks, especially in older patients.

The companies making CAS devices received a boost earlier this month with report of a proposed national coverage decision by the Centers for Medicare & Medicaid Services to expand coverage to a broader patient pool that might be treated with these stents and via this interventional procedure (Medical Device Daily, Feb. 6, 2006). Under the proposed policy, asymptomatic patients under age 80, who are at high risk for surgery and have 80% or greater carotid artery stenosis, would be eligible for coverage outside of a post-market study or clinical trial, as long as the procedure is performed using the FDA-approved carotid artery stent systems and embolic protection devices in a facility approved by CMS.

Carotid stents are inserted via a small puncture in the groin and threaded through the blood vessels and up into the carotid artery in the neck. The goal is to clear the arteries of fat deposits that clog those vessels and can break off, drift to the brain and cause strokes.

Cordis, of course, is banking on the quick exchange feature to give it strong entry into the CAS space against the competition. Other companies who have RX versions of carotid artery stents approved in the U.S. include ev3 (Plymouth, Minnesota), Abbott Laboratories (Abbott Park, Illinois) and Boston Scientific (Natick, Massachusetts). ev3 reported FDA approval of its Protégé RX carotid stent in January (Medical Device Daily, Jan. 29, 2007).

Cordis is further bringing more data to this marketing dance, promoting the newly-approved system as the only one backed by a large, randomized clinical trial — the SAPPHIRE study — to support the potential benefits of CAS in patients who are ineligible, or considered high-risk, for carotid endarterectomy.

"No other carotid artery stent and embolic protection system has been studied as extensively in as wide a range of high-risk patients as the Precise RX Nitinol Self-Expanding Stent and Angioguard RX Emboli Capture Guidewire System and we intend to continue building upon this important body of clinical evidence," Donohoe added.

Anil Chhabra, MD, Willis-Knighton Medical Center (Shreveport, Louisiana), performed the first carotid case with the Precise RX Nitinol Self-Expanding Stent and Angioguard RX Emboli Capture Guidewire System in the U.S.

"It's great to get the same devices on the rapid exchange delivery system. The Angioguard RX Emboli Capture Guidewire System was very easy to advance through a very tight lesion and the auto tapering of the Precise RX Nitinol Self-Expanding Stent was apparent in the excellent wall apposition across the different sized internal and common carotid arteries," Chhabra said.

Carotid artery disease is the buildup of atherosclerotic plaque in the major neck vessels delivering blood to the brain, a major cause of stroke. CAS is a minimally invasive, non-surgical procedure intended to improve blood flow to the brain while helping prevent debris from entering cerebral circulation, and an important alternative for patients who are ineligible for CEA.

Those more likely to have carotid artery disease are older people, those with a family history of stroke, those with plaque buildup in other areas of the body, and those with high blood pressure, and diabetes.

The American Heart Association (Dallas) estimates that 20% to 30% of strokes are associated with carotid artery disease, caused by particles of atherosclerotic plaque traveling into the vessels that supply the brain with oxygen and vital nutrients. Stroke affects an estimated 700,000 Americans each year, making it the nation's third leading cause of death, and a leading cause of serious, long-term disability.

Cordis Endovascular also reported the initiation of Sapphire Worldwide, a 10,000 patient global registry to assess the 30-day rate of major adverse events (death, stroke or myocardial infarction) following the placement of a stent in high surgical risk patients with carotid artery disease. The stent procedure includes use of an emboli distal protection system — designed to contain and remove plaque or debris from the artery during the procedure. The registry will include up to 275 centers with low, medium and high annual carotid stent implant volumes, from both academic and private hospitals.

Cordis is a business of Johnson & Johnson (New Brunswick, New Jersey).