Enrollment Phase of Genesis MedTech’s Early Feasibility Study of J-Valve Transfemoral System Concludes

February 5, 2024—Genesis MedTech announced the completed enrollment of an early feasibility study (EFS) looking at the company’s transcatheter aortic valve replacement (TAVR) system, the J-Valve transfemoral (TF) system. Study enrollment began late last year in October.

According to the company, the trial evaluates symptomatic patients with severe aortic regurgitation (AR) across five centers in the United States. Patients who met the inclusion criteria received treatment using the J-Valve TF system. The trial has been approved by the FDA.

The last patient was enrolled at MedStar Washington Hospital Center, in Washington, DC, by Drs. Ron Waksman and Lower Satler.

Dr. Michael Reardon, a Coprincipal Investigator of the study, commented in the company’s press release, “The J-Valve being a dedicated TAVR design has shown promise in treating patients with AR. We are pleased with our findings to date from our EFS and look forward to the successful initiation of the pivotal trial.” Dr. Reardon is Professor of Cardiothoracic Surgery, Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist Hospital in Houston, Texas.

Dr. Dean Kereiakes, President of the Christ Hospital Heart and Vascular Institute in Cincinnati, Ohio, serves alongside Dr. Reardon as Coprincpal Investigator of the trial.

The J-Valve TF system was previously granted FDA Breakthrough Device designation for the proposed indication of treating severe native AR and AR-dominant mixed aortic valve disease. According to Genesis MedTech, the procedure is performed through a minimally invasive TF approach, without the need for open heart procedure or extracorporeal circulation.

The J-Valve TF System is for investigational device use only in the United States and Canada.