A ‘tie-breaker’ study of Abbott’s heart clip brings more questions than answers
Aug. 31, 2024
FDA Reporter
A study meant to serve as a tie-breaker between two major trials of a heart clip made by Abbott may end up stimulating more debate among cardiologists.
Results of the RESHAPE-HF 2 trial, presented at the European Society of Cardiology meeting and published in the New England Journal of Medicine on Saturday, showed that the clip improved health status and lowered hospitalizations due to heart failure, but did not reduce the number of deaths.
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The device is meant to treat patients with mitral regurgitation, a condition where blood leaks backward into the left heart chamber. It can cause uncomfortable symptoms like fatigue and in severe cases, can lead to heart failure. Abbott’s device, called the MitraClip, works by clipping the mitral valve’s leaflets together to prevent blood leakage.
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