The US FDA Grants Conditional Approval to Initiate Second Cohort of the EFS Study of CARMAT’s Aeson Artificial Heart
Shots:
- The US FDA has granted conditional approval to initiate the second cohort of the early feasibility study (EFS) of the Aeson artificial heart in the US by H2’25, pending ethics committee approval & personnel training; launch expected by 2028
- EFS is being conducted in 2 cohorts; first (n=3) was completed in Q3’21, leading to FDA-approved enhancements to Aeson. 2nd cohort will incl. 7 pts, with an interim report on the first 3, as CARMAT seeks the US FDA approval to use the updated version of Aeson in the study
- EFS will assess pts survival at 6mos. post-Aeson implant, or a successful heart transplant within that period, as the 1EP
Ref: CARMAT | Image: CARMAT
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
