Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
Boston Scientific starts Synergy study: Enrollment has begun in the randomized, single-blind, non-inferiority EVOLVE clinical trial comparing the firm's fourth-generation Synergy bioabsorbable polymer/everolimus-eluting stent to its Promus Element everolimus-eluting stent in patients with single de novo native coronary artery lesions, Boston Scientific announces Aug. 3. The primary clinical endpoint is target lesion failure at 30 days, a composite measure of cardiac death, myocardial infarction and target lesion revascularization, and the primary angiographic endpoint is in-stent late loss at six months. Synergy is designed to offer restenosis reduction with faster and more complete vessel healing after stent implantation, Boston Scientific says. EVOLVE will be used to support a CE mark for Synergy, which was previously called Evolution. The firm said recently it is anticipating a mid-2012 U.S. launch of Promus Element, already available in Europe
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