Boston Scientific Corporation announced the beginning of patient enrollment in the PLATINUM clinical trial, which is designed to evaluate the Company’s PROMUS™ Element™ Everolimus-Eluting Coronary Stent. The first European patient was enrolled on 29 January 29 at Pauls Stradins Clinical University Hospital in Latvia by Andrejs Erglis, M.D., Ph.D., F.E.S.C., F.A.C.C., Head of the Latvian Centre of Cardiology, and President of the Latvian Society of Cardiology.
The PLATINUM clinical programme will enroll 1,728 patients at 160 sites worldwide. The trial will compare the PROMUS Element Everolimus-Eluting Coronary Stent to the PROMUS™ Everolimus-Eluting Coronary Stent. The Company plans to develop additional variations of the Element Stent platform, including next generations of a bare-metal stent and a paclitaxel-eluting TAXUS® Element Stent.
The Element Stent platform features a proprietary Platinum Chromium Alloy, designed specifically for coronary stents. This alloy, coupled with a new stent architecture, is designed to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. In addition, the PROMUS Element Stent System incorporates the new Apex™ Dilatation Catheter technology, designed to enhance deliverability to complex lesions.
“I’m delighted to have enrolled the first European patient into this groundbreaking international trial,” said Dr Erglis. “PROMUS Element Stents have an innovative design and architecture, and have the potential to deliver the benefits of percutaneous coronary intervention to patients with complex anatomy and lesions. The development of both everolimus and paclitaxel stents with this new system should be welcomed by interventional cardiologists.”
The global Principal Investigator for the trial is Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation in New York. The International Co-Principal Investigator is Ian Meredith, M.D., Ph.D., Director of Cardiology at the Monash Medical Centre in Melbourne, Australia.
The Company plans to launch PROMUS Element in Europe during the fourth quarter of this year. The PROMUS Element and TAXUS Element Stent Systems are investigational devices and are limited by applicable law to investigational use only and are not available for sale.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.