The VenusP-Valve (Venus Medtech) transcatheter pulmonic valve replacement (TPVR) system has been approved by China’s National Medical Products Administration (NMPA) for the treatment of severe pulmonary regurgitation in patients who have undergone a congenital heart defect (CHD) procedure with native right ventricular outflow tract (RVOT).
For the registration application, the NMPA has accepted trial data submitted to support the device’s CE mark approval, which was received in April 2022. The device was approved by the US Food and Drug Administration (FDA) for compassionate use in two cases in the USA in May 2022 and the first compassionate case was completed successfully in June 2022.
Following its first clinical implantation in 2013, VenusP-Valve has been used in nearly 300 cases for humanitarian reasons, spanning more than 20 countries and regions in Asia, Europe, North America, and South America, Venus Medtech said in a press release.
According to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusP-Valve is 100% in 64 patients (some patients have not been included due to the ongoing pandemic), the company adds. 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, five-year follow-up data of the Chinese trial reported a 3.64% postoperative five-year all-cause mortality rate.
Commenting on the approval, Ge Junbo (Zhongshan Hospital, Shanghai, China), principal Investigator of the Chinese clinical trial of VenusP-Valve, said: “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 multicentre 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 USA demonstrated the recognition it received from the international medical community. That is how a truly meaningful innovative medical device is defined.”