Healthcare Industry News: Self-expanding Stent
News Release - March 13, 2006
New Data Demonstrate Carotid Artery Stenting in Clinical Practice Has Comparable Major Adverse Event Rate With That Seen in Pivotal SAPPHIRE TrialData presented at ACC meeting corroborate findings of landmark study on carotid artery stenting in high surgical-risk patients
WARREN, N.J., March 13 (HSMN NewsFeed) -- Cordis Endovascular, a division of Cordis Corporation, announced today that preliminary results of its CASES peri-approval study (CASES-PMS) showed that high surgical-risk patients treated with carotid artery stenting (CAS) had identical 30-day major adverse event (MAE) rates with that of patients treated with CAS in the pivotal SAPPHIRE study. The data, which were presented today at the American College of Cardiology Scientific Sessions, showed an MAE rate of 4.8 percent (62/1279) among patients treated with CAS in CASES-PMS compared with 4.8 percent (8/167) of CAS-treated patients in the randomized arm of the SAPPHIRE trial.
CASES-PMS is a multi-center, prospective, single arm open-label peri- approval study designed to assess the outcomes of stenting with Cordis' PRECISEŽ* Nitinol Self-expanding Stent, and ANGIOGUARD(TM) XP* Emboli Capture Guidewire System in the treatment of obstructive artery disease in relation to the outcomes of the pivotal SAPPHIRE study. The study's primary objective is to demonstrate that outcomes in a peri-approval setting, including use of a detailed training program in CAS for physicians not experienced in CAS, allow outcomes that are similar to those obtained in the pivotal trial setting.
"These initial findings are very important because they both corroborate the findings of the landmark SAPPHIRE study, and demonstrate that formalized training in carotid stenting allows physicians from multiple specialties with prior endovascular experience to perform carotid stenting and obtain outcomes as good as the experts that performed the clinical trials," said Dennis Donohoe, M.D., Vice President, Worldwide Regulatory and Clinical Affairs, Cordis Corporation. "The outcomes in this study are an important additional set of data supporting the generalizability of results from the SAPPHIRE trial, the only randomized clinical trial of carotid stenting compared to carotid endarterectomy."
Cordis Endovascular initiated CASES, its comprehensive training program for physicians and other relevant healthcare professionals, in 2004. This training included didactic review, case observations and simulation training, and hands-on experience at the Regional Education Centers across the country.
The CASES-PMS study is intended to validate the effectiveness of the training program. Preliminary data indicate that physicians who completed the entire training program demonstrated MAE and stroke rates that were comparable with those of the overall study. Overall, the rate of stroke at 30 days was 3.6% (46/1279) while the rate of stroke in patients treated by physicians who completed the entire training program was 3.7% (3/82).
Sidney A. Cohen, M.D., Ph.D., Cordis Corporation said, "We are very encouraged by these results because the CASES program was designed for patients with fewest treatment options, who are at risk for stroke due to carotid artery disease, but who are poor candidates for surgery."
CASES-PMS enrolled 1,493 patients at over 70 sites in the United States; preliminary data presented today was on the first 1,279 enrolled patients. The study enrolled high surgical-risk patients with de novo atherosclerotic or post-endarterectomy restenotic obstructive lesions in native carotid arteries. Inclusion and exclusion criteria matched those in the SAPPHIRE study. Clinical follow-up was conducted at 30 days, and will be conducted again one year post procedure. The 30-day assessments include a neurological examination and an evaluation of adverse events. The 30-day MAE rate was defined as the 30-day composite of all death, myocardial infarction (MI) and stroke. Clinical events at one year also will be assessed.
Cordis Endovascular is a recognized leader in endovascular research and development. The company has the resources to make breakthrough treatments possible along with the reputation for delivering trusted, quality products and value that is expected by our customers.
Cordis Endovascular is a worldwide supplier of interventional and diagnostic medical products including nitinol and stainless steel stents, vena cava filters, balloon catheters and accessories. The company is committed to serving the cardiology, radiology and vascular surgery communities through the development of groundbreaking technologies for the treatment of peripheral vascular disease.
The company constantly seeks solutions to the human anatomy's most challenging problems, such as carotid artery disease, aortic aneurysm, superficial femoral artery disease and venous thrombotic disease.
* The Cordis PRECISE Nitinol Stent System and Cordis ANGIOGUARD Emboli Capture Guidewire System are investigational devices, limited by Federal (or United States) Law to investigational use.
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