Venus Medtech’s transcatheter pulmonic valve replacement (TPVR) system—VenusP-Valve—has received CE marking under the Medical Devices Regulation (MDR) to be marketed in Europe.
Designed to treat patients with moderate to severe pulmonary regurgitation with or without right ventricular outflow tract (RVOT) stenosis, the device is designed with both flared ends, intended to provide stable anchoring and easy delivery, with no need for pre-stenting before the procedure.
Following its first clinical implantation in 2013 by Ge Junbo (Zhongshan Hospital, Fudan University, Shanghai, China) the valve has been used in nearly 300 cases for humanitarian reasons, spanning more than 20 countries in Asia, Europe, North America, and South America, Venus Medtech says. In March 2021, VenusP-Valve received special use authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for use in designated medical institutions.
Moderate to severe pulmonary regurgitation is common after surgical correction of congenital heart disease. It leads to right ventricular volume overload and may cause arrhythmia and even sudden death in the long term. The traditional thoracotomy approach to pulmonic valve replacement is difficult and carries high mortality, while existing TPVR products in the European market, due to their balloon-expandable design, apply to patients with particular anatomic structures only and require pre-stenting, Venus Medtech adds
Apart from the EU, VenusP-Valve is undergoing review and approval of registration with the Chinese National Medical Products Administration (NMPA) and is expected to be marketed within 2022. With plans to launch clinical trials in the USA in 2023, Venus Medtech is preparing for its investigational device exemption (IDE) application to the US Food and Drug Administration (FDA).
Shakeel Qureshi (Evelina London Children’s Hospital, London, UK), principal investigator (PI) of the clinical trial for CE marking of VenusP-Valve, said: “I still remember the first procedure we performed in September 2016 in London and its excellent immediate outcomes,” he said. “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.”
“For Venus Medtech, the CE marking of VenusP-Valve under MDR will open a new chapter of growth in the European market,” said Eric Zi, co-founder, executive director, and general manager of the company. “We will leverage this product to scale up our overseas revenue, accelerating our progress to global prosperity. Also, we will continue our clinical trials and commercialisation endeavours in global markets for other innovative technologies and products, bringing Chinese innovations to the world.”