Boston Scientific's 3rd-generation Synergy drug-eluting stent lands CE Mark approval in the European Union.
Boston Scientific (NYSE:BSX) said it won CE Mark approval for its Synergy drug-eluting stent, with a bioabsorbable coating designed to deliver the drug everolimus over the 3 months it takes to dissolve.
The company said Synergy is slated for limited release in the European Union and elsewhere by early 2013, with a broader commercial launch on deck for early 2014. The stent is built on Boston Scientific's platinum-chromium chassis, which the Natick, Mass.-based medical device company touts as more visible under X-ray and able to be built with thinner, more flexible struts.
The CE Mark application was based on BSX's Evolve trial comparing the Synergy device with its Promus Element DES. The Synergy's coating is applied only to the exterior of the stent, whereas the Promus Element's coating is applied to the interior and exterior.