A Medical Device Daily
Boston Scientific (Natick, Massachusetts) reported 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 U.S. patient was enrolled last week at the Medical Center of the Rockies (Loveland, Colorado) by Thomas Downes, MD.
The PLATINUM clinical program will enroll 1,728 patients at 160 sites worldwide. The company said it 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 platinum chromium alloy, designed specifically for coronary stents. This alloy, coupled with new stent architecture, is designed to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. Also, the Promus element stent system uses the new Apex dilatation catheter technology, designed to enhance deliverability to complex lesions.
"We are excited to begin evaluating the everolimus version of our third-generation Element Stent," said Keith Dawkins, MD, senior VP and associate chief medical officer for Boston Scientific. "The advanced Platinum Chromium Alloy and new balloon catheter offered in the Element Stent System represent significant improvements. Boston Scientific is the only company to offer interventional cardiologists a choice of two different drugs on its drug-eluting stent platform."