Free Newsletter
Register for our Free Newsletters
Analysis, Inspection and Laboratory
Assisted/Independent Living
Clinical and Nursing Equipment
Design and Manufacture of Medical Equipment
Diagnostics Equipment, Monitoring and Test
Education, Training and Professional Services
Health Education and Patient Management
Health Estates Management
Healthcare Support and Information Services
Hygiene and Infection Control
IT and Communications in Healthcare
Medical Device Technology
Research and Development
Safety and Security
View All
Other Carouselweb publications
Carousel Web
Defense File
New Materials
Pro Health Zone
Pro Health Zone
Pro Security Zone
Web Lec
Pro Engineering Zone

Boston Scientific begins European Registry to assess different Olimus-eluting stents

Boston Scientific : 11 February, 2008  (New Product)
Boston Scientific has been enrolled the first patient in its PROENCY (Promus, ENdeavor and CYpher) European registry 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-labelled Xience V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. The Promus Stent is an investigational device in the USA with its Premarket Approval (PMA) application currently under review by the US 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 revascularisation) at 12 months.

The Promus, Cypher and Endeavor Stents have previously been investigated in randomised 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. The trial compared Xience V (Promus) with the market-leading Taxus Express2 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.
Bookmark and Share
Home I Editor's Blog I News by Zone I News by Date I News by Category I Special Reports I Directory I Events I Advertise I Submit Your News I About Us I Guides
   © 2012
Netgains Logo