Genesis MedTech Begins EFS for J-Valve Transfemoral TAVR System

October 23, 2023—Genesis MedTech, a medical device company headquartered in Singapore, announced initiation of enrollment in the North American early feasibility study (EFS) of the company’s J-Valve transfemoral (TF) transcatheter aortic valve replacement (TAVR) system. The company noted that completion of the first successful implantation under the FDA-approved EFS is part of a broad clinical program that will investigate the treatment of patients with aortic regurgitation (AR).

The study’s first procedure was performed by Dean Kereiakes, MD, and Santiago Garcia, MD, with their team at The Lindner Research Center at The Christ Hospital in Cincinnati, Ohio. Dr. Kereiakes is President of the Christ Hospital Heart and Vascular Institute and national coprincipal investigator for the study.

“Having treated patients under a compassionate-use protocol, we developed an appreciation for the unique features of the J-Valve TF system,” commented Dr. Kereiakes in the company’s press release. “We are pleased to report that the first early feasibility case using a 34-mm J-Valve yielded similar favorable results. The J-Valve TF system could potentially revolutionize the treatment of aortic regurgitation, allowing larger annular sizes to be treated.”

The company stated that the design and features of the J-Valve TF system are intended to potentially help patients with aortic valve regurgitation with no approved options for treatment in the United States.

The J-Valve TF system was developed by California-based JC Medical, which was acquired by Genesis MedTech in 2022. JC Medical was granted Breakthrough Device designation for the J-Valve for the proposed indication of treating severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in patients who are determined by a heart team to be eligible for the device and to be at high risk for surgical aortic valve replacement. The J-Valve TF System is an investigational device in the United States and Canada, advised Genesis Medtech.