Novel, less invasive Half Moon transcatheter mitral repair device to treat common heart valve disease

UPMC Heart and Vascular Institute in Central Pa. today announced that its doctors treated a patient using the Half Moon Medical transcatheter mitral repair technology (Half Moon TMVr System). This technology uses a less invasive approach to treat mitral regurgitation, a disease where blood leaks backwards within the heart due to the valve's inability to close properly. Mitral regurgitation is a common heart valve disease in the U.S. affecting an estimated four million people.

The Half Moon TMVr System, which is designed to restore function in a diseased mitral valve, is only available as part of UPMC Heart and Vascular Institute in Central Pa.'s participation in the ongoing Half Moon TMVr System Pilot Study. The study is evaluating the safety and performance of the Half Moon TMVr System in high risk patients with severe, symptomatic mitral regurgitation. If left untreated, the disease can lead to chronic heart failure, the leading cause of hospitalization.

The Half Moon TMVr System is currently investigational, meaning it is not approved by the FDA for general, commercial use. Although the study is currently ongoing, researchers said the use of this device has initially shown promise in sustained reduction of mitral regurgitation. UPMC Heart and Vascular Institute in Central Pa. is the latest group to implant the device, following six other clinical trial cases in the U.S. and Australia.

"There are severe forms of valve leakage, and mitral regurgitation would be the most common that merits intervention," said Hemal Gada M.D., president of UPMC Heart and Vascular Institute in Central Pa., who led the procedure. "Left untreated, severe symptomatic mitral regurgitation can cause serious complications. In those severe cases, patients require invasive treatment which has historically been open-heart surgery. The Half Moon TMVr System provides similar treatments for patients using a much less invasive approach."

The Half Moon TMVr System is unique from other mitral valve repair technologies in maintaining more natural function of the mitral valve. It is inserted through a catheter that is threaded through a vein in the patient's leg through the body and up to the diseased mitral valve. The device is fully repositionable and recoverable during the procedure. This device may provide a potential treatment option for patients with complex anatomy not ideal for treatment with currently FDA-approved mitral technologies, who qualify for this clinical trial. The Half Moon TMVr Study is designed to enroll approximately 30 patients to be treated with this device.

"This technology is designed to eliminate regurgitation by restoring the natural physiologic functionality of the mitral valve," said Matt McLean, CEO and Co-Founder of Half Moon Medical, the sixteenth Foundry company, founded in 2017. "On behalf of the entire team at Half Moon, I would like to congratulate the team at UPMC Heart and Vascular Institute in Central Pa. on this incredible achievement."

Provided by University of Pittsburgh Schools of the Health Sciences