JenaValve wins FDA nod for Trilogy heart valve system

JenaValve announced today that it received FDA premarket approval (PMA) for its Trilogy THV system.

Trilogy, a transcatheter heart valve (THV) system, won approval for the treatment of patients with symptomatic, severe aortic regurgitation (AR) at high or greater risk for surgical aortic valve replacement (SAVR).

Trilogy is now the first and only transcatheter device approved in the U.S. with a dedicated indication for this patient population. The company says symptomatic, severe AR remains significantly undertreated  while posing a life-altering threat to patients. Trilogy is already available in Europe.

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