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CroíValve wins FDA IDE for tricuspid heart valve

CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system.

The beginning of the study follows FDA investigational device (IDE) approval. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR).

Duo features a coaptation valve that works in tandem with the native tricuspid valve to restore valve function. Delivered using percutaneous techniques, Duo is secured using a novel anchor system. This anchor system leaves the right heart and native valve apparatus untouched.

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