CE Mark for Drug-Eluting Stent

Published date : 01 November 2012
Article date : 01 November 2012


Massdevice reports that medical device manufacturer, Boston Scientific, has announced that it has won CE Mark approval for its Synergy drug-eluting stent. The device has a bioabsorbable coating which is designed to deliver everolimus over the 3 months that it takes the drug to dissolve. The company plans to release the device in Europe, on a limited basis, then elsewhere by early 2013 followed by a wider launch in 2014.
Apparently, the CE Mark application was based on Boston Scientific's 'Evolve trial' which compared the Synergy device with the company's Promus Element DES. The Synergy device coating is applied only to the exterior of the stent whereas the Promus Element's coating is applied to both the interior and exterior. 
The article says that the 291 patient Evolve study compared 2 versions of the Synergy device with the Promus Element. One of the Synergy arms received stents coated with a half-dose of everolimus, the other with a full dose. The results from the study were published in the April issue of the Journal of the American College of Cardiology. They showed that the Synergy stent met its primary safety endpoints (target lesion failure at 30 days) and its efficacy endpoints (in-stent late loss at 6 months). Boston Scientific said the Synergy device posted a target lesion revascularization rate of 1.1% and a 0% rate of stent thrombosis after a year.
Source: Massdevice, 31 October 2012
Read the full article here.
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