Genesis MedTech has announced the completion of enrolment in its US early feasibility study (EFS) using its dedicated transcatheter aortic valve implantation (TAVI) platform, the J-Valve transfemoral system.
The US Food and Drug Administration (FDA) approved EFS trial involved patient enrolment at five centres across the USA. The trial focused on evaluating symptomatic individuals with severe aortic regurgitation (AR).
The last patient was successfully enrolled by Ron Waksman and Lowell Satler (MedStar Washington Hospital Center, Washington DC, USA). The EFS co-principal Investigators were Dean Kereiakes (Christ Hospital Heart and Vascular Institute, Cincinnati, USA) and Michael Reardon (Houston Methodist Hospital, Houston, USA). Patients meeting the inclusion criteria received treatment using the J-Valve transfemoral system. The outcomes of this clinical experience will be presented later this year.
“TAVI has proven results for patients with aortic stenosis. An unmet need remains for patients with AR,” Reardon commented. “The J-Valve being a dedicated TAVI 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.”
Developed by JC Medical, the J-Valve TF system has been granted breakthrough device designation for the proposed indication of treating severe native 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 transfemoral system can potentially help patients that suffer from aortic valve regurgitation, currently lacking approved treatment options in the USA.
“This accomplishment would not have been possible without the dedicated efforts of the investigators and research teams involved,” stated Mark A Turco, CEO of JC Medical and president of vascular intervention, North America, at Genesis MedTech. “We look forward to the data and learnings as well as the initiation of our upcoming Pivotal Trial.”
The J-Valve transfemoral system is an investigational device in the USA and Canada.
