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Boston Scientific Gets CE Mark Approval For SYNERGY Stent - Quick Facts

Boston Scientific Corp. (BSX) said it received CE Mark approval for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System featuring an ultra-thin abluminal (outer) bioabsorbable polymer coating.

The SYNERGY Stent is the latest innovation in drug-eluting stent technology from Boston Scientific. It is unique in that its proprietary PLGA polymer and everolimus drug coating dissipate by three months. This innovation has the potential to improve post-implant vessel healing and will eliminate long-term polymer exposure, a possible cause of late adverse events.

The SYNERGY Stent is supported by a rigorous clinical program builds on the EVOLVE six-month study results which demonstrated non-inferiority to the Boston Scientific PROMUS Element Stent for the primary angiographic endpoint of in-stent late loss, a proxy for efficacy. At 12 months, the SYNERGY Stent demonstrated a target lesion revascularization rate of 1.1 percent and a stent thrombosis rate of 0.0 percent.

The SYNERGY Stent will be available in a full range of sizes to select centers in Europe and other geographies by early 2013. This limited market release is expected to provide additional data to support the clinical and economic benefits of this novel bioabsorbable technology. A broad commercial launch of the SYNERGY Stent is planned for early 2014.

by RTT Staff Writer

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