Enrollment Completion
Genesis MedTech, a leading medical device company, today announced the completion of enrollment in its United States Early Feasibility Study (EFS) using its dedicated transcatheter aortic valve replacement (TAVR) system, J-Valve™ Transfemoral (TF) System. Finalizing the EFS marks another significant milestone for Genesis MedTech and its U.S.-based subsidiary JC Medical.
EFS Trial
The FDA approved EFS trial involved patient enrollment at five centers across the United States. The trial focused on evaluating symptomatic individuals with severe Aortic Regurgitation. The last patient was successfully enrolled by Drs. Ron Waksman and Lowell Satler, MedStar Washington Hospital Center, Washington, DC. The EFS Co-Principal Investigators were Dr. Dean Kereiakes, President of the Christ Hospital Heart and Vascular Institute, Cincinnati, OH. and Dr. Michael Reardon, Professor of Cardiothoracic Surgery, Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist Hospital, Houston, TX. Patients meeting the inclusion criteria received treatment using the J-Valve™ TF system. The outcomes of this clinical experience will be presented later this year.
“TAVR has proven results for patients with Aortic Stenosis. An unmet need remains for patients with Aortic Regurgitation,” Dr. Reardon commented. “The J-Valve™ being a dedicated TAVR design has shown promise in treating patients with aortic regurgitation. We are pleased with our findings to date from our EFS and look forward to the successful initiation of the pivotal trial.”
J-Valve Developed by JC Meeical
Developed by JC Medical, the J-Valve™ TF System has been granted Breakthrough Device designation for the proposed indication of treating severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. Patients are assessed by a heart team to be eligible for the device and at high risk for surgical aortic valve replacement. The procedure is performed through a minimally invasive transfemoral approach, without the need for open-heart procedure or extracorporeal circulation. The innovative design and features of the J-Valve™ TF System can potentially help patients that suffer from aortic valve regurgitation, currently lacking approved treatment options in the United States.
Dr. Mark A. Turco, CEO of JC Medical and President of Vascular Intervention North America at Genesis MedTech
“This accomplishment would not have been possible without the dedicated efforts of the investigators and research teams involved. We look forward to the data and learnings as well as the initiation of our upcoming Pivotal Trial.”
The J-Valve ™ TF System is an investigational device in the United States and Canada.