NATICK, Mass., Feb. 11 Boston ScientificCorporation (NYSE: BSX) today announced that the first patient has beenenrolled in its PROENCY (PROMUS(TM), ENdeavor(R) and CYpher(R)) Europeanregistry. The registry is the first to observe different 'Olimus'-elutingcoronary stents. It will collect real-life clinical outcome data for BostonScientific's PROMUS(TM) Everolimus-Eluting Coronary Stent and compare themwith data from Johnson & Johnson's Cypher(R) Sirolimus-Eluting Stent andMedtronic's Endeavor(R) Zotarolimus-Eluting Stent in patients in routineclinical practice. The PROMUS Stent is a private-labeled XIENCE(TM) VEverolimus-Eluting Coronary Stent System manufactured by Abbott anddistributed by Boston Scientific. The PROMUS Stent is an investigationaldevice in the United States with its Premarket Approval (PMA) applicationcurrently under review by the U.S. Food and Drug Administration.
"I am excited to enroll the first patient into this innovative newregistry," said Professor Christian Hamm, Principal Investigator, KerckhoffHeart Center, Bad Nauheim, Germany. "We have previously seen efficacy datafrom clinical trials with the PROMUS, Cypher and Endeavor stents but data fromthis registry will allow us, for the first time, to comparatively assess thedifferences between everolimus-, sirolimus- and zotarolimus-eluting stents inpatients with simple and complex lesions. This should help clinicians inmaking the appropriate stent choice for their patients."
The registry will enroll up to 2,500 patients with simple and complexlesions at multiple sites in several European countries. Of the patients ateach site, half will receive the PROMUS Stent and half will receive either theCypher or the Endeavor Stent to attain a 2:1:1 ratio of PROMUS, Cypher, andEndeavor Stents respectively. The primary endpoint of the registry will bethe rate of major cardiac events (cardiac death, all myocardial infarction andtarget vessel revascularization) at 12 months.
The PROMUS, Cypher and Endeavor Stents have previously been investigatedin randomized clinical trials. Twelve-month data from the SPIRIT III Trial,presented in October 2007 at the Transcatheter Cardiovascular Therapeuticsconference in Washington, confirmed earlier positive clinical results for theXIENCE V (PROMUS) Stent. This trial compared XIENCE V (PROMUS) with themarket-leading TAXUS(R) Express2(TM) Paclitaxel-Eluting Stent, demonstratingnon-inferiority in the primary endpoint of in-segment late loss at eightmonths with no safety concerns at 12 months.
Boston Scientific is the first company to offer European physicians andtheir patients a choice of two distinct drug-eluting stent platforms: TAXUSand PROMUS.
TAXUS and PROMUS are trademarks of Boston Scientific Corporation or itsaffiliates. XIENCE is a trademark of the Abbott Laboratories group ofcompanies. 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 ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visit:www.bostonscientific.com.
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