Venus Medtech’s VenusP-Valve TPVR System Approved in Europe

April 11, 2022—China-based Venus Medtech (Hangzhou) Inc. announced that the VenusP-Valve, the company’s in-house–developed transcatheter pulmonic valve replacement (TPVR) system, received European CE Mark approval.

According to the company, the VenusP-Valve is designed to treat patients with moderate to severe pulmonary regurgitation with or without right ventricular outflow tract (RVOT) stenosis.

The self-expanding TPVR device is designed with both flared ends and provides stable anchoring and easy delivery with no need for prestenting. The VenusP-Valve TPVR device is suitable for different anatomical structures and available in a wide range of specifications, stated the company.

The first clinical implantation of the device was performed in 2013 by Ge Junbo, MD, Director of Cardiology at Zhongshan Hospital, Fudan University, in Shanghai, China. Since then, VenusP-Valve has been implanted in approximately 300 humanitarian-use procedures in more than 20 countries and regions in Asia, Europe, North America, and South America. In March 2021, VenusP-Valve received special use authorization from the United Kingdom's Medicines and Healthcare products Regulatory Agency for use in designated medical institutions.

Professor Shakeel Qureshi, MD, of Evelina London Children's Hospital in London, United Kingdom, served as Principal Investigator of the clinical trial that supported the application for VenusP-Valve’s CE Mark approval.

Clinical data supporting the VenusP-Valve’s long-term safety and efficacy include 2-year follow-up interim results of the clinical study in Europe in which the device demonstrated 100% procedural success, with no reoperation or death observed in 2 years. In addition, moderate pulmonary regurgitation decreased from 16.88% preoperatively to 0%, and severe pulmonary regurgitation decreased from 83.12% to 1.54%. The data suggest excellent performance, robust safety and reliability, and drastic and steady improvements in patients’ cardiac function, stated the company.

In Venus Medtech’s press release Prof. Qureshi commented, “I still remember the first procedure we performed in September 2016 in London and its excellent immediate outcomes. On that starting point, we continued to recruit additional patients for the trial. The overall clinical results underscored the sustained, effective, and steady improvements the product brings to patients’ cardiac function. This is what a truly meaningful innovative medical device looks like.”

Venus MedTech noted that the VenusP-Valve was approved as a Class III implantable cardiovascular device under the European Commission's Medical Devices Regulation (MDR) that took effect in May 2021. The new MDR sets out stricter and more specific standards in technical review and clinical evaluation and requires the establishment of expert panels to support such evaluations.

The company further advised that the VenusP-Valve is undergoing review and approval of registration with the Chinese National Medical Products Administration and is expected to be marketed within 2022. Venus Medtech is preparing for its investigational device exemption application to the FDA with plans to launch clinical trials in the United States in 2023.