JenaValve Technology has received premarket approval from the FDA for its Trilogy THV System.
The system is now the first transcatheter device in the U.S. with a dedicated indication for patients with symptomatic, severe aortic regurgitation, according to a March 18 news release from the company.
The FDA approval is supported by a study that displays successful results with the Trilogy THV System. JenaValve will launch activity with the system with clinical study sites and new hospitals.
There are tens of thousands of individuals in the U.S. each year who are identified as having symptomatic, severe AR, the release said.
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