Venus Medtech’s VenusP-Valve Approved in China

July 20, 2022—Venus Medtech recently announced that the company’s VenusP-Valve 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 procedure with native right ventricular outflow tract (RVOT).

The VenusP-Valve approval in China comes after European CE Mark approval, which was announced in April 2022. The product was approved by the FDA for compassionate use in two cases in the United States in May 2022 and the first compassionate case was completed in June 2022.

According to the company, the VenusP-Valve TPVR system, which is designed with both flared ends, ensures the blood flow of the branchial artery with bare stents at the outflow end. It provides a stable multipoint anchoring system and enables easy delivery, with no need for prestenting before the procedure. VenusP-Valve is available in a variety of specifications with extensive applicability and is able to meet the needs of 85% of patients in the case of large RVOT, advised the company.

For the registration application, the NMPA has accepted the overseas CE-Mark clinical trials data of VenusP-Valve as clinical evaluation data.

In addition to approval in China and Europe, the Japan-United States Harmonization By Doing Program was agreed upon by the FDA and Japan’s Pharmaceutical and Medical Device Agency with a plan to conduct clinical trials in the United States and Japan simultaneously, which will accelerate its registration and marketing in both countries.

The company reported that the 3-year follow-up data of the European clinical trial showed a success rate of 100% for TPVR with VenusP-Valve in 64 patients (some patients have not been included because of the ongoing pandemic). All-cause mortality and surgical reintervention rates were zero. In addition, no moderate or severe pulmonary regurgitation was observed. Paravalvular leakage and tricuspid regurgitation were mild or below in 96.87% of subjects. Meanwhile, 5-year follow-up data of the Chinese trial reported a 3.64% postoperative 5-year all-cause mortality rate.

Academician Professor Ge Junbo, Director of Cardiology Department at Zhongshan Hospital Affiliated to Fudan University Shanghai, China, is the principal investigator of the Chinese clinical trial of VenusP-Valve.

Prof. Junbo commented in the company’s press release, “The first clinical application of VenusP-Valve dated to May 2013, and we were all impressed by its excellent immediate outcomes. The overall clinical results of the multicenter study testified to effective and steady improvements it brought to patients’ cardiac function, making me extremely proud of this Chinese-developed valve product. Moreover, its recent launch in Europe and compassionate use in the United States demonstrated the recognition it received from the international medical community. That’s how a truly meaningful innovative medical device is defined.”