Boston Scientific has received CE Mark for the Promus Element everolimus-eluting coronary stent system, its third-generation drug-eluting stent (DES) technology.
The Promus Element system, using a platinum chromium alloy, is being evaluated in the PLATINUM clinical trial, which completed enrollment of 1,532 patients in September at more than 140 sites worldwide. PLATINUM is a randomized, controlled, pivotal trial designed to support FDA and Japanese Ministry of Health, Labor and Welfare approval of the DES.
The Natick, Mass.-based company said it will begin marketing the Promus Element system immediately in the European Union and other CE Mark countries. CE Mark was granted by the Dutch Notified Body KEMA Quality.