First-In-Human Procedure Performed in Early Feasibility Study of Half Moon's TMVR Device

January 11, 2021—The Foundry announced the successful completion of the first-in-human procedure with the Half Moon Medical transcatheter mitral valve repair technology at Oregon Health and Science University (OHSU) in Portland, Oregon. The procedure was part of an 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 was developed through a partnership between Medtronic and The Foundry. The device is designed to restore function in a diseased mitral valve in patients with severe symptomatic mitral regurgitation.

According to the company, the procedure was co-led by Howard Song, MD, and Firas Zahr, MD. Dr. Song is cardiothoracic surgery division chief at OHSU. Dr. Zahr is OHSU interventional cardiology director. Scott Chadderdon, MD, OHSU Knight Cardiovascular Institute clinical trials director, led echocardiography to guide the procedure.

“Minimally invasive transcatheter heart valve repair can offer relief from mitral valve regurgitation without the need for traditional open-heart surgery,” commented Dr. Song in the company’s announcement. Dr. Zahr added, “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.”

The Half Moon mitral valve repair device is designed to maintain the 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 reintervention in the future, stated The Foundry.