Expanded CE Mark Enables Label Update for Coronary Stents

Published date : 26 October 2012
Article date : 25 October 2012


Mass Device reports that medical device manufacturer, Boston Scientific, has gained an expanded CE Mark which will enable the company to update the label directions for the use of its Promus Element Plus coronary stents. They say that the new labels can also include clinical guidelines for 3 month dual anti-platelet drug therapy (DAPT), for specific patients.

According to the manufacturer, they will introduce the new labelling in CE Mark countries. 

Apparently, Boston Scientific also announced that its next-generation Synergy stent may address some of the issues associated with durable stent polymers, such as those on Promus Element and Promus Plus, by using a bioresorbable polymer that dissolves within 3 months of implantation. 

Source: Mass Device, 24 October 2012

Read the original article here.

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