February 11, 2008 - Boston Scientific Corp. today announced that the first patient has been enrolled in its PROENCY (PROMUS, ENdeavor and CYpher) European registry, a registry designed to observe different “Olimus”-eluting coronary stents.
The registry will collect real-life clinical outcome data for Boston Scientific’s PROMUS Everolimus-Eluting Coronary Stent and compare them with data from Johnson & Johnson’s Cypher Sirolimus-Eluting Stent and Medtronic's Endeavor Zotarolimus-Eluting Stent in patients in routine clinical practice. The PROMUS Stent is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. The PROMUS Stent is an investigational device in the U.S. with its Premarket Approval (PMA) application currently under review by the FDA.
The registry will enroll up to 2,500 patients at multiple sites in several European countries. Of the patients at each site, half will receive the PROMUS Stent and half will receive either the Cypher or the Endeavor Stent to attain a 2:1:1 ratio of PROMUS, Cypher, and Endeavor Stents respectively. The primary endpoint of the registry will be the rate of major cardiac events (cardiac death, all myocardial infarction and target vessel revascularization) at 12 months.
For more information: www.bostonscientific.com