Transcatheter mitral valve replacement system receives FDA breakthrough device status
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Abbott announced its transcatheter mitral valve replacement system has received a breakthrough device designation from the FDA.
As a result of the designation, the application for approval of the device (Tendyne) may receive a faster review from the FDA. Products selected for breakthrough designation are granted priority review and their sponsors can interact with FDA personnel to address topics as they arise during the review, according to the agency.
According to an email sent to Healio from Abbott, the breakthrough designation for its investigational Tendyne system is for a subset of patients with severe mitral annular calcification, which is often associated with mitral valve stenosis and mitral regurgitation, in need of mitral valve replacement. These patients are not candidates for open-heart surgery.
As Healio previously reported, at 2 years, 93% of patients had trace or no mitral regurgitation.
The system received a CE Mark in 2020.
Editor's Note: This article was updated on June 22, 2021 to clarify the patient population.
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