FDA Expands TAVR Indication To Low-Risk Patients
As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.
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The first half of November was full of cardiovascular device news, led by clinical trial results from renal denervation and transcatheter aortic valve trials presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference.
September has been full of cardiovascular technology news, including announcements from Biotronik and Biosense Webster. Here are a few of the highlights.
Fourth-quarter sales of Edwards Sapien transcatheter aortic valve systems grew 2% year-over-year overall, despite the intense challenges created by COVID-19.