PROENCY will provide real-world clinical data on the PROMUS(TM) Stent
NATICK, Mass., Feb. 11 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that the first patient has been enrolled in its PROENCY (PROMUS(TM), ENdeavor(R) and CYpher(R)) European registry. The registry is the first to observe different 'Olimus'-eluting coronary stents. It will collect real-life clinical outcome data for Boston Scientific's PROMUS(TM) Everolimus-Eluting Coronary Stent and compare them with data from Johnson & Johnson's Cypher(R) Sirolimus-Eluting Stent and Medtronic's Endeavor(R) Zotarolimus-Eluting Stent in patients in routine clinical practice. The PROMUS Stent is a private-labeled XIENCE(TM) V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. The PROMUS Stent is an investigational device in the United States with its Premarket Approval (PMA) application currently under review by the U.S. Food and Drug Administration.
"I am excited to enroll the first patient into this innovative new registry," said Professor Christian Hamm, Principal Investigator, Kerckhoff Heart Center, Bad Nauheim, Germany. "We have previously seen efficacy data from clinical trials with the PROMUS, Cypher and Endeavor stents but data from this registry will allow us, for the first time, to comparatively assess the differences between everolimus-, sirolimus- and zotarolimus-eluting stents in patients with simple and complex lesions. This should help clinicians in making the appropriate stent choice for their patients."
The registry will enroll up to 2,500 patients with simple and complex lesions 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.
The PROMUS, Cypher and Endeavor Stents have previously been investigated in randomized clinical trials. Twelve-month data from the SPIRIT III Trial, presented in October 2007 at the Transcatheter Cardiovascular Therapeutics conference in Washington, confirmed earlier positive clinical results for the XIENCE V (PROMUS) Stent. This trial compared XIENCE V (PROMUS) with the market-leading TAXUS(R) Express2(TM) Paclitaxel-Eluting Stent, demonstrating non-inferiority in the primary endpoint of in-segment late loss at eight months with no safety concerns at 12 months.
Boston Scientific is the first company to offer European physicians and their patients a choice of two distinct drug-eluting stent platforms: TAXUS and PROMUS.
TAXUS and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of the Abbott Laboratories group of companies. Endeavor is a trademark of Medtronic Vascular Incorporated. Cypher is a trademark of Cordis Corporation, a Johnson & Johnson company.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.
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CONTACT: Paul Donovan
Boston Scientific Corporation
Boston Scientific Corporation
|SOURCE Boston Scientific Corporation|
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