Monday, Boston Scientific Corp. (BSX) reported that it has received the CE Mark to market its third-generation drug-eluting stent or DES technology, called the Promus Element Everolimus-Eluting Coronary Stent System.
The company medical device maker said that the Promus Element Stent platform features a proprietary Platinum Chromium Alloy, designed specifically for coronary stents. This alloy, along with a new stent design will enable thinner struts, more flexibility and a lower profile while improving radial strength, recoil and visibility, compared with older alloys such as the cobalt chromium alloy used in the XIENCE PRIME DES. Also, the Promus Element Stent System incorporates the new Apex Dilatation Catheter technology, which provides more consistent lesion coverage and drug distribution.
"The platinum chromium alloy and new stent design used in the PROMUS Element stent represent significant innovations in drug-eluting stent technology," said Bruno Farah, Clinique Pasteur, Toulouse, France. "In my experience, the Element platform offers a stenting option that provides superior deliverability and visibility with excellent comformability and low recoil. I believe it offers performance improvements that could simplify procedures and allow treatment of a broader range of patients," Farah added.
In addition to the Promus Element Everolimus-Eluting Coronary Stent System, Boston Scientific said that it plans to offer the Taxus Element Paclitaxel-Eluting Coronary Stent System, which will also incorporate the platinum chromium alloy with the innovative stent design and advanced catheter delivery system.
Boston Scientific anticipates FDA approval for the Promus Element system in 2012. The Taxus Element system, which was launched in select international markets in May is expected to receive CE Mark approval in the second quarter of 2010, and FDA approval in 2011.
The Promus Element system is being evaluated in the PLATINUM clinical trial, which has completed enrollment of 1,532 patients in September at more than 140 sites worldwide. PLATINUM is a randomized, controlled, pivotal trial designed to support U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approval of the Promus Element system. The Taxus Element system is being evaluated in the PERSEUS trial, which completed enrollment in October 2008 and will report primary endpoint data at the American College of Cardiology conference in March.
BSX is currently trading on the New York Stock Exchange at $8.17, up $0.05 or 0.62%.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.