The Foundry announces first-in-human procedure in study of Half Moon TMVR device

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The Foundry today announced the completion of the first-in-human procedure with the Half Moon Medical transcatheter mitral repair technology (TMVR) at Oregon Health and Science University (OHSU), Portland, USA, as part of a US Food and Drug Administration (FDA) approved early feasibility study. The first patient treated has been discharged from the hospital and is recovering as expected.

The investigational Half Moon mitral valve repair device, developed through a partnership between Medtronic and The Foundry, is designed to restore function in a diseased mitral valve in patients with severe symptomatic mitral regurgitation (MR), a disease where blood leaks backwards within the heart due to the mitral valve’s inability to close properly.

“We are pleased to be able to offer our patients new options for heart valve repair as early as possible through studies such as this,” said Firas Zahr, OHSU interventional cardiology director, who co-led the procedure.

“Minimally invasive transcatheter heart valve repair can offer relief from mitral valve regurgitation without the need for traditional open-heart surgery,” said Howard Song, OHSU cardiothoracic surgery division chief, who co-led the procedure. Scott Chadderdon, OHSU Knight Cardiovascular Institute clinical trials director, also led echocardiography to guide the procedure.

In a press release, The Foundry said that the Half Moon mitral valve repair device is unique from other mitral valve repair technologies in maintaining more natural physiologic functionality of the mitral valve. It is deployed using a transfemoral delivery catheter, which is navigated through the vasculature to the diseased native mitral valve. The device is fully repositionable and recoverable during deployment and preserves options for patients who may need re-intervention in the future.

“This technology is a truly innovative solution designed to eliminate regurgitation by restoring physiologic coaptation of the native mitral valve,” said Matt McLean, co-founder and chief operating officer at Half Moon Medical, founded in 2017. “On behalf of the entire team at Half Moon, I would like to congratulate the team at OHSU on this incredible achievement.”


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