Boston Scientific is beginning clinical trials for a new drug-coated stent made out of a platinum alloy.
The Promus Element everolimus-eluting coronary stent is one of two new Boston Scientific stents made from a proprietary blend of platinum and chromium. Stents are tiny metal mesh tubes that are used to prop open heart vessels after coronary artery disease treatment.
The first patients in Boston Scientific’s study were enrolled last week, one in Colorado and another in Japan. Investigators at the Columbia University Medical Center and the Cardiovascular Research Foundation in New York plan to enroll 1,728 patients by October.
Boston Scientific announced a clinical trial in October for another platinum-chromium stent called the Taxus Element paclitaxel-eluting coronary stent, which is coated with a different type of drug. The company hopes the alloy material, which it developed with the help of NASA research, will replace stainless steel and cobalt chromium in its next generation of stents.
Jeff Mirviss, Boston Scientific’s vice president for marketing, tells Business Agenda that the alloy has several advantages over materials in existing stents. The metal’s properties allow the stent’s structures to be “very, very thin,” Mirviss said. The platinum-chromium stents are flexible enough to adapt to curves, and it is significantly easier to view on an X-ray images, he said.
The clinical trial Boston Scientific announced today is a “pivatol milestone” in moving the product closer toward FDA approval. The company hopes to have the platinum-chromium stents on the market in the United States in 2011 and 2012.
Research, development and manufacturing for Boston Scientific’s drug-coated stents takes place at facilities in Ireland and Maple Grove.
