VenusP-Valve(TM) Obtains CE Mark Under MDR and Debuts in Europe as China’s First Valve Product

0

As the first self-expanding TPVR product approved for commercialization in EuropeVenusP-ValveMT has remarkable clinical value. Uniquely designed with both flared ends, the product provides stable anchorage and easy placement, with no need to pre-stent before the procedure. Available in a variety of specifications with wide applicability, the product is able to meet the needs of 85% of patients. Following its first clinical implantation in 2013 by Academician Ge Junbo, Director of Cardiology at Zhongshan Hospital, Fudan University, VenusP-ValveMT has been used in nearly 300 cases for humanitarian reasons, covering more than 20 countries and regions in Asia, Europe, North Americaand South America. In March 2021VenusP-ValveMT has received special use authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for use in designated medical establishments.

Moderate to severe pulmonary regurgitation is common after surgical correction of congenital heart disease. It leads to right ventricular volume overload and can lead to long-term arrhythmia or even sudden death. The traditional thoracotomy approach for pulmonary valve replacement is difficult and results in high mortality, while existing TPVR products in the European market, due to their balloon-expandable design, are only applicable to patients with structures particular anatomical features and require pre-stenting. In addition, since these valves are small in diameter, they only work for 15 to 20% of patients. Before VenusP-Valve certificationMTthere was no TPVR product suitable for different anatomical structures and available in such a wide range of specifications.

VenusP valveMT has impressive clinical data confirming its long-term safety and efficacy. According to the interim result of a two-year follow-up of the clinical study conducted in Europe, the product demonstrated 100% procedural success, with no reoperations or deaths seen in two years. Additionally, moderate lung regurgitation decreased from 16.88% preoperatively to 0%, and severe lung regurgitation dipped from 83.12% to 1.54%. The data suggests excellent performance, robust safety and reliability, and drastic and steady improvements in patients’ heart function.

As published on the EU MDR website, VenusP-ValveMT is the first class III implantable cardiovascular device approved under the new MDR. Entry into force in May 2021, the new regulations establish stricter and more specific standards for technical examination and clinical evaluation and require the establishment of expert panels to support these evaluations. After the adoption of the new rules, no CE MDR certificate has been issued to any class III implantable cardiovascular device until VenusP-ValveMTwhich is irrefutable proof of Venus Medtech’s world-class clinical testing and quality control systems.

Europe is the bridgehead of Venus Medtech’s international strategy. Building a winning go-to-market team for VenusP-ValveMTthe company has hired marketing veterans like Shakeel Osman and David Breant as senior managers. Now VenusP-ValveMT received pre-orders of several million euros.

Outside the EU, VenusP-ValveMT is undergoing China National Medical Products Administration (NMPA) registration review and approval and is expected to be commercialized by 2022. With plans to begin clinical trials in the United States in 2023, Venus Medtech is preparing for its investigational device exemption (IDE) application to the FDA. Apparently, the EU approval will give an important boost to the marketing processes in Chinathe United States and other markets.

Teacher Shakeel Qureshi to Evelina London Children’s Hospital, Principal Investigator (PI) of the clinical trial for the CE marking of VenusP-ValveMT, congratulated Venus Medtech on the EU approval of the product. “I still remember the first operation we performed in September 2016 in London and its excellent immediate results,” he said. “From this starting point, we continued to recruit additional patients for the trial. The overall clinical results underscored the sustained, effective and consistent improvements the product brings to patients’ heart function. This is what a truly meaningful innovative medical device looks like.”

“For Venus Medtech, the CE marking of VenusP-ValveMT 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 increase our overseas revenues, accelerating our progress towards global prosperity. In addition, we will continue our clinical trials and commercialization efforts in global markets for other innovative technologies and products, bringing Chinese innovations to the world.

SOURCE Venus Medtech (Hangzhou) Inc.

For more information: Jie Liu, +86-13222987087

Share.

Comments are closed.