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.

Medical device giants Edwards Lifesciences Corp. and Boston Scientific Corp. have obtained new CE marks on their transcatheter aortic valve replacement (TAVR) products, the companies announced at the ongoing Paris Course of Revascularization (PCR) London Valves meeting in London.

Edwards’ Sapien 3 valve has been granted a CE mark to use the device in patients suffering from severe, symptomatic aortic stenosis who are at intermediate risk for open-heart surgery....

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