Boston Scientific Becomes Third US TAVR Competitor With Lotus Edge Approval

The US FDA approved Boston Scientific's Lotus Edge transcatheter aortic valve for patients who would be at high risk with surgical valve replacement. Unlike competing TAVR systems from Medtronic and Edwards, Lotus Edge can be repositioned or recaptured after it has been deployed.

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Boston Scientific Corp. immediately began a limited US launch of its Lotus Edge mechanically expanded transcatheter aortic valve replacement (TAVR) system after the US Food & Drug Administration approved it on 23 April.

Lotus Edge will compete with Edwards Lifesciences Corp.'s Sapien 3 balloon-expandable valve and Medtronic’s CoreValve Evaluate R self-expanding valve in the US TAVR market.

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