VenusP-Valve(TM) receives CE marking under MDR and debuts in Europe as China’s first valve product
HANGZHOU, China, April 11, 2022 /PRNewswire/ — On April 8, 2022, VenusP-ValveTM, the in-house of Venus Medtech, developed the innovative Transcatheter Pulmonic Valve Replacement (TPVR) system, which is known as the Medical Devices Regulation (MDR). Got CE marking under 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 VenusP-ValvTM is the first Chinese-made artificial heart valve approved in Europe, adding to the global presence of China’s innovative medicine There is a new milestone. Device.
As the first self-expanding TPVR product approved for marketing in Europe, VenusP-ValveTM holds remarkable clinical value. Uniquely designed with both flared ends, the product provides stable anchoring and easy delivery, with no need for pre-stenting prior to the procedure. Available in various specifications with wide applicability, the product is able to meet the needs of 85% of the patients. Since its first clinical transplant in 2013 by academician Ge Junbo, director of cardiology at Fudan University’s Zhongshan Hospital, VenusP-ValvTM has been used for humanitarian reasons in about 300 cases, spread across Asia, Europe, North America. are spread in more than 20 countries and regions. , and South America. In March 2021, VenusP-ValvTM received a 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. This leads to right ventricular volume overload and can cause arrhythmias and even sudden death in the long run. The traditional thoracotomy approach to pulmonary valve replacement is difficult and carries a high mortality rate, whereas existing TPVR products in the European market, due to their balloon-expandable design, are applicable only to patients with specialized anatomical structures and require pre-stenting. is required. Also, since these valves come in smaller diameters, they only work for 15% to 20% of patients. Prior to VenusP-ValveTM’s certification, there was no TPVR product suitable for various structural structures and available in such a wide range of specifications.
VenusP-ValveTM has impressive clinical data supporting its long-term safety and efficacy. According to interim results of a two-year follow-up of clinical studies in Europe, the product demonstrated 100% procedural success, with no relapses or deaths observed at two years. In addition, moderate pulmonary regurgitation decreased from 16.88% formerly to 0%, and severe pulmonary regurgitation decreased from 83.12% to 1.54%. The data suggest excellent performance, robust safety and reliability, and massive and steady improvement in patients’ cardiac function.
As published on the EU MDR website, the VenusP-ValveTM is the first Class III implantable cardiovascular device approved under the notably new MDR. After taking effect in May 2021, the new regulations set stricter and more specific standards in technical review and clinical evaluation and require the establishment of expert panels to support such assessment. Following the adoption of the new regulations, no CE MDR certificate was issued to any class III implantable cardiovascular device until VenusP-ValvTM, a clear testament to Venus MedTech’s world-class clinical testing and quality control system .
Europe is the bridge between Venus MedTech’s international strategy. To create a winning commercialization team for VenusP-ValvTM, the company enlisted marketing stalwarts such as Shakeel Usman and David Brent as senior managers. So far, VenusP-ValveTM has received pre-orders worth several million euros.
In addition to the European Union, VenusP-ValvTM is undergoing registration review and approval with the Chinese National Medical Products Administration (NMPA) and is expected to be marketed within 2022. With plans to begin clinical trials in the US in 2023, Venus MedTech is preparing its investigational device exemption (IDE) application to the FDA. Obviously, the EU approval will give a significant impetus to commercialization processes in China, the US and other markets.
Professor Shakeel Qureshi at Evelina London Children’s Hospital, Principal Investigator (PI) of the clinical trial for the CE marking of VenusP-ValvTM, congratulated Venus MedTech on the EU approval of the product. “I still remember the first procedure in London in September 2016 and its excellent immediate results,” he said. “At that starting point, we continued to enroll additional patients for the trial. The overall clinical results underscored the continuous, effective and steady improvements the product brought about by the product in patients’ heart function. This was truly a worthwhile innovation. Looks like a medical device.”
“For Venus MedTech, the CE marking of VenusP-ValvTM under the MDR will open a new chapter of development in the European market,” said Eric Zee, the company’s co-founder, executive director and general manager. “We will leverage this product to increase our overseas revenue, accelerating our progress to global prosperity. In addition, we will expand our clinical trials and commercialization efforts into global markets for other innovative technologies and products. Will continue, bringing Chinese innovations to the world.”
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Source Venus MedTech (Hangzhou) Inc.
