The J-Valve TF System received breakthrough device designation for the proposed indication of treating severe native AR and AR-dominant mixed aortic valve disease. Credit: Natali _ Mis / Shutterstock.com.

Genesis MedTech has commenced enrolment in its North American early feasibility Study using its J-Valve Transfemoral (TF) system for patients with severe aortic regurgitation (AR).

Dr Dean Kereiakes and Dr Santiago Garcia, along with the team at the Lindner Research Center at The Christ Hospital in Cincinnati, Ohio, US, carried out the procedure with the system.

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The study is part of a broad clinical programme aimed at studying the treatment of patients with AR.

Developed by JC Medical, the J-Valve TF system received breakthrough device designation for the proposed indication of treating severe native AR and AR-dominant mixed aortic valve disease.

It is intended for patients who are determined by a heart team to be eligible for treatment using the device and those at high risk for surgical aortic valve replacement.

Genesis MedTech Group chairman and CEO Warren Wang said: “We are fully dedicated to conducting rigorous clinical trials and fostering collaborations with healthcare professionals to ensure the highest standards of product safety and efficacy.

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“With the successful implantation of J-Valve F System, Genesis MedTech is poised to address critical medical needs and make a positive impact on patients’ lives.”

J-Valve TF System is currently under investigation in Canada and the US.

Genesis MedTech Vascular Intervention North America president and JC Medical CEO Dr Mark Turco said: “This achievement demonstrates our dedication to advancing medical technology in the structural heart disease sector.

“Collaborating with leading TAVR sites across the US and Canada, we hope to demonstrate results that will highlight the unique ability of a dedicated TAVR valve like J-Valve in treating patients with a life-threatening disorder.”