Cordis Endovascular has received U.S. Food and Drug Administration (FDA) approval for primary stenting of the iliac arteries with the S.M.A.R.T. Nitinol Stent and the S.M.A.R.T. Control Nitinol Stent. A nine-month multicenter, prospective randomized clinical trial documented the safety and efficacy of the S.M.A.R.T. Nitinol Stent System in treating iliac artery blockages -- the most common form of peripheral vascular disease.

The study, known as CRISP (Cordis Randomized Iliac Stent Project), was sponsored by Cordis Endovascular, a division of Cordis Corporation, a Johnson & Johnson company. The trial was designed to study equivalency to the Wallstent Iliac Endoprosthesis, the control device in the CRISP Trial.

The S.M.A.R.T. Nitinol Stent System is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries, with angiographic evidence of a patent profunda or superficial femoral artery.

The CRISP study compared the performance of the S.M.A.R.T. Stent with that of the Wallstent a stainless-steel, self-expanding stent. The goal was to confirm that the two stents offer comparable efficacy and safety. "In all major variables evaluated, the S.M.A.R.T. Stent either matched or exceeded the performance of the Wallstent," said CRISP Investigator, Thomas O. McNamara, Section Chief, Interventional Radiology, UCLA Department of Radiological Sciences, Los Angeles, CA.

CRISP included 203 patients (102 randomized to treatment with the S.M.A.R.T. Stent, and 101 randomized to treatment with the Wallstent Iliac Endoprosthesis) who initially failed angioplasty. Primary clinical endpoints were evaluated at nine months post procedure with follow-up out to 12 months. Mean lesion length was 24.6 mm and 38% of lesions involved the external iliac artery.

Dr. McNamara attributes the higher procedural success rate of the S.M.A.R.T. Stent to the fact that nitinol stents are easier to position than self-expanding stainless steel stents. He noted that in four cases, the Wallstent Iliac Endoprosthesis did not deploy in the intended location, requiring an additional stent placement, versus zero misplacements in the S.M.A.R.T. Stent group.

The S.M.A.R.T. Stent, introduced in 1999, is also approved to treat biliary obstructions. "We now have substantial clinical evidence to confirm its efficacy and safety in treating the most common form of peripheral vascular disease," said Dr. Donohoe. "This approval, together with last year's clearance of the Palmaz Renal Stent, demonstrates Cordis' commitment to evidence-based medicine through clinical trials."

Peripheral vascular disease, generally defined as atherosclerotic blockages in vessels that carry blood to organs and structures outside the heart, affects an estimated 10 million people in the U.S. Occlusive iliac artery disease, the most common form of peripheral vascular disease, can seriously impede the flow of blood to the legs. People with this condition typically experience leg pain and numbness, or tingling, due to poor circulation. Restoration of adequate blood flow through the iliac artery is essential to maintaining leg function and avoiding complications, the most severe being gangrene.