The J-Valve system, which has FDA breakthrough device status, is intended for transcatheter aortic valve replacement procedures
Genesis MedTech finishes enrollment in TAVR study of J-Valve system. (Credit: valelopardo from Pixabay)
Singapore-based Genesis MedTech has concluded the enrollment for the US Early Feasibility Study (EFS) of its J-Valve Transfemoral (TF) System involving patients with severe aortic regurgitation (AR).
Developed by JC Medical, the American subsidiary of Genesis MedTech, the J-Valve system is intended for transcatheter aortic valve replacement (TAVR) procedures.
The system has breakthrough device designation from the US Food and Drug Administration (FDA) to treat severe native AR and AR-dominant mixed aortic valve disease.
According to Genesis MedTech, a cardiac team evaluates patients to determine if they are high-risk candidates for surgical aortic valve replacement and suitable for the device.
The procedure with the device is executed via a minimally invasive transfemoral method, thereby eliminating the need for extracorporeal circulation or open-heart procedures.
Genesis MedTech stated that the J-Valve TF System’s design and features are suitable for patients with aortic valve regurgitation, as there are presently no authorised treatments for this condition in the US.
Genesis MedTech North America vascular intervention president and JC Medical CEO Mark Turco said: “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 FDA-accepted EFS study enrolled patients from five locations across the US. It focuses on evaluating symptomatic individuals having severe AR.
The last patient was registered at the MedStar Washington Hospital Center in Washington, DC.
Genesis MedTech said that the patients who met the inclusion criteria were administered with treatment using the J-Valve TF system. The results from this clinical experience are expected to be shared later this year.
In September last year, the medical device company received approval from China’s National Medical Products Administration (NMPA) for the market launch of its absorbable sutures with antibacterial protection.