Genesis MedTech J-VALVE® TF Approved by NMPA, China's First Transfemoral TAVR for Aortic Regurgitation

Clinical data demonstrate low mortality, fewer complications and faster patient recovery with a minimally invasive alternative to open-heart surgery

SINGAPORE, Sept. 17, 2025 /PRNewswire/ -- Genesis MedTech's structural heart subsidiary, Suzhou Jiecheng, has received approval from China's National Medical Products Administration (NMPA) for the J-VALVE® Transfemoral Transcatheter Aortic Valve Replacement (TAVR) System (J-VALVE TF), the first transfemoral TAVR system approved in China for the treatment of aortic regurgitation.

Aortic regurgitation is a progressive and potentially life-threatening condition that remains undertreated despite being one of the more common valvular heart diseases worldwide. While open-heart surgery has long been the standard of care, many elderly or high-risk patients are not suitable candidates. Moreover, most TAVR solutions have been developed and approved for aortic stenosis, leaving patients with aortic regurgitation with few minimally invasive treatment options.

The J-VALVE TF offers an alternative to open-heart surgery by using a minimally invasive transfemoral approach. This reduces surgical trauma and procedural risk while shortening procedure time, with most patients walking the day after treatment. Its patented anchoring design further enhances safety by ensuring secure valve placement, protecting coronary flow and reducing the risk of complications such as paravalvular leak and conduction block.

At EuroPCR 2024, Professor Wei Lai of Zhongshan Hospital, Fudan University, presented 12-month follow-up results on J-VALVE TF:

- 3.2% all-cause mortality

- 94.5% free from third-degree atrioventricular block

- Demonstrated improvements in cardiac function and hemodynamic performance

"Behind every innovation lies a patient. We are excited as this approval brings new hope to patients with severe aortic regurgitation who previously had few safe options." said Warren Wang, Chairman and CEO of Genesis MedTech. "With J-VALVE TF, we can now offer patients a minimally invasive solution that is safer and a faster path to recovery.  "

About Genesis MedTech Group

Genesis MedTech Group is a global medical device company headquartered in Singapore, dedicated to Making Better Healthcare Happen. We design and develop innovations that make treatments safer, less invasive and more accessible at scale, supporting healthcare providers in achieving improved patient outcomes and ensuring more patients benefit from medical advances. With integrated capabilities from R&D and manufacturing to commercialization, Genesis MedTech builds on a strong foundation of quality, training and education - delivering high-quality medical devices across surgical, cardiology, and vascular interventional specialties.

Learn more at https://www.genesismedtech.com and follow us on LinkedIn

SOURCE Genesis MedTech