BURLINGAME, Calif., Oct. 23, 2023 /PRNewswire/ — Genesis MedTech, a leading medical device company, today announced initiation of enrolment in its North American Early Feasibility Study using its dedicated TAVR system, J-Valve™ Transfemoral (TF) System. The procedure was successfully performed by Dr. Dean Kereiakes, MD, Dr. Santiago Garcia, MD, and the team at The Lindner Research Center at The Christ Hospital in Cincinnati, Ohio on October 16, 2023.
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 in patients who are determined by a heart team to be eligible for the device and to be 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 with no approved options for treatment in the United States.
"Having treated patients under a compassionate use protocol, we developed an appreciation for the unique features of the J-Valve TF system," commented Dr. Kereiakes, President of the Christ Hospital Heart and Vascular Institute and National Co-Principal Investigator for the study. "We are pleased to report that the first Early Feasibility case using a 34mm J-Valve yielded similar favourable results. The J-Valve™ TF System could potentially revolutionize the treatment of aortic regurgitation, allowing larger annular sizes to be treated."
The completion of the first successful implantation under the FDA-approved Early Feasibility Study marks a significant milestone for Genesis MedTech. Dr Mark A. Turco, CEO JC Medical and President of Vascular Intervention North America at Genesis MedTech shared, "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." The North American EFS is part of a broad clinical program that will investigate the treatment of patients with aortic regurgitation.
Genesis MedTech continues to prioritize patient safety. Warren Wang, Chairman & CEO of Genesis MedTech Group, emphasized the company’s commitment by stating, "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. With the successful implantation of J-Valve™ TF System, Genesis MedTech is poised to address critical medical needs and make a positive impact on patients’ lives." The J-Valve TF System is an investigational device in the United States and Canada.
ABOUT GENESIS MEDTECH & JC MEDICAL
Based in Burlingame California, JC Medical Inc., under Genesis MedTech Group, is a structured heart company that is primarily engaged in the design and development of transcatheter valve replacement products for the minimally invasive treatment of structural heart diseases.
Genesis MedTech Group is a medical device company headquartered in Singapore. Founded by a group of professionals and entrepreneurs with MedTech experience globally and in Asia, the company’s product portfolio focuses on multi-therapy medical device products for emerging markets with sales and distribution through its established commercial network. Genesis MedTech Group covers the entire industry value chain of research and development, production, quality management, supply chain, marketing, and sales.
For more information, visit http://www.genesismedtech.com & https://j-valve.com
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