Edwards, Boston Sci Make TAVR Progress In Europe
Edwards Lifesciences' Sapien 3 transcatheter aortic heart valve is now labeled in Europe for use in patients who face an intermediate risk from open-heart surgery, matching a recent US development. Meanwhile, Boston Scientific's next-generation Lotus Edge TAVR device gained a CE mark.
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The Cardioband system is a transcatheter annuloplasty device for repair of mitral and tricuspid valves that should be a natural fit with Edwards transcatheter mitral valve development program. Israel-based Valtech had a deal in September 2015 to be acquired by HeartWare for $900m, but that deal fell through after HeartWare investors protested.
OUS Approvals Analysis: BSX, Edwards Score New CE Marks In TAVR Battlefield; Chinese DES Advances In Asia
September's list of devices approved outside the US include a new transcatheter aortic valve in Europe, two orthopedic devices and a gynecology device in Australia, and a drug-eluting stent in Pakistan.
The expanded indication for Edwards' Sapien XT and Sapien 3 arrives about when the company had predicted.