Cardiovalve Wins FDA Breakthrough Device Designation for Tra
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Cardiovalve announced that it received FDA Breakthrough Device Designation for its Transcatheter Tricuspid Valve Replacement System. The company also received approval for an Early Feasibility Study of the device for tricuspid and mitral valve regurgitation indications.

The Cardiovalve transcatheter system is designed for the treatment of mitral and tricuspid regurgitation by the replacement of native valves via a transfemoral approach. Using a transfemoral procedure allows surgeons to offer a minimally-invasive alternative to open-heart surgery or transapical delivery with mini-thoracotomy access.

It is also designed with an enhanced seal to prevent paravalvular leaks. Initial clinical results demonstrate high procedural success, and the first patients have had a sustained clinical benefit for more than two years.

Amir Gross, CEO of Cardiovalve, said “We now have clinical data two years out that our implant is functioning as expected and the patient is improved clinically. FDA’s ‘breakthrough’ designation validates and reaffirms our commitment to improving and extending the lives of millions of patients suffering from heart valve disease across the world.”

Source: https://www.medgadget.com/2020/03/cardiovalve-wins-fda-breakthrough-device-designation-for-transcatheter-tricuspid-valve-replacement-system.html#
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