September 18, 2009 – Boston Scientific today said it completed patient enrollment in the workhorse portion of its PLATINUM clinical program, a global, randomized, pivotal controlled trial designed to support FDA and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the platinum-chromium PROMUS Element Everolimus-Eluting Coronary Stent System.
The trial enrolled 1,532 patients with up to two de novo lesions at more than 140 sites worldwide, and completed enrollment two months ahead of schedule.
The PLATINUM workhorse trial evaluates the new PROMUS Element in comparison with the current PROMUS stent, which uses the same drug dose and polymer on an earlier cobalt-chromium alloy stent design. Two parallel subtrials will evaluate the PROMUS Element in small vessels and long lesions. In addition to the PROMUS Element Everolimus-Eluting Stent, the company is developing additional variations of a bare-metal and paclitaxel-eluting stent on the Element platform. The pivotal PERSEUS clinical trial compares the TAXUS Element stent to the TAXUS Express2 stent. The PERSEUS trial completed enrollment in October 2008, and the primary endpoint will be reported at the ACC conference in 2010.
"The brisk enrollment in the PLATINUM trial reflects the strong interest in this new platinum chromium stent platform," said Gregg W. Stone, M.D., professor of medicine and the director of research and education at the Center for Interventional Vascular Therapy at the Columbia University Medical Center/New York-Presbyterian Hospital and principal investigator of the trial.
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 allow thinner struts, increased flexibility and a lower profile, while improving radial strength, recoil and visibility. In addition, all three Element stents incorporate the new Apex Dilatation Catheter technology, designed to enhance deliverability, Boston Scientific said.
The PROMUS Element, TAXUS Element and bare-metal Element stents are investigational devices and are limited by applicable law to investigational use only and are not available for sale.
For more information: www.bostonscientific.com