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Valcare Medical receives US FDA approval to initiate EFS for Amend transseptal system

Summary by Cardiovascular News

Valcare Medical Logo Valcare Medical has announced the US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to commence an early feasibility study (EFS) for the Amend transseptal system. The Amend transseptal system is a transcatheter device intended for treatment of mitral insufficiency with a semi rigid, closed, D-shaped annuloplasty ring that mimics today’s surgical gold standard. The EFS will evaluate the saf…

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Cardiac Interventions Today

Valcare Medical Receives IDE Approval for EFS of Amend Transseptal System - Cardiac Interventions Today

March 17, 2025—Valcare Medical Inc. recently announced that the FDA has approved the company’s investigational device exemption (IDE) application for the early feasibility study (EFS) of the Amend transseptal system for the treatment of mitral insufficiency. The company noted that the Amend device features a semirigid, closed, D-shaped annuloplasty ring that mimics the current gold standard of surgical treatment. According to Valcare, the EFS wi…

16 days ago

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