VenusP-Valve™ approved by China’s NMPA

On July 11, 2022, VenusP-Valve™, Venus Medtech’s in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, was approved by China’s National Medical Products Administration (NMPA) for the treatment of severe pulmonary regurgitation (≥3+) in patients after congenital heart defects (CHD) procedure with native right ventricular outflow tract (RVOT). The approval has made VenusP-Valve™ the first TPVR product to be marketed in China, marking another milestone following its CE MDR approval. 

As the first self-expanding TPVR product approved in both China and Europe, VenusP-Valve™ sets itself apart with remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve™ is able to meet the needs of 85% of patients in the case of large RVOT.

“The fast-tracked approval of VenusP-Valve™ would not be possible without CMDE’s generous support. Their patient-centric orientation is an important driver in promoting innovative medical devices”, commented Eric Zi, Co-Founder, Executive Director, and General Manager of Venus Medtech. “As one of the first companies to work on transcatheter structural heart devices in China, we have always embraced a clinical value-oriented approach to innovation. Aspiring to lead technological advances in our country, we are committed to delivering unprecedented, groundbreaking products in China and beyond. The approval of VenusP-Valve™ in China is another key milestone following its CE MDR approval. Filling a gap in China’s TPVR market, the product is expected to benefit more patients across the country.”