Loma Vista Medical has announced it has received FDA clearance for its balloon valvuloplasty catheter, according to a news release (pdf).
The TRUE Dilatation balloon valvuloplasty catheter is designed to prevent balloon ruptures in TAVI and BAV procedures.
"There is an unmet clinical need for a high performance, dimensionally consistent and structurally reliable balloon for BAV and TAVI," said Alex Tilson, CEO of Loma Vista, in the relase. "Loma Vista Medical is the world's only company that has a state-of-the-art solution which is now cleared in the United States and approved throughout Europe."
Loma Vista Medical is headquartered in Burlingame, Calif.
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