First American Patient Treated with VenusP-Valve™ Under Compassionate Use

HANGZHOU, China, June 22, 2022 /PRNewswire/ -- VenusP-Valve™, an in-house developed novel medical device of Venus Medtech (Hangzhou) Inc. (2500.HK, hereinafter referred to as "Venus Medtech"), recently completed its first compassionate use at University of Virginia Advanced Cardiac Valve Center in the U.S.

The procedure was performed at the Center by Professor Scott Lim's team under on-site guidance from Professor Yuan Feng and remote guidance from Professor Mao Chen, who are both from Cardiology Department, West China Hospital, Sichuan University in China. As the first-ever clinical application of a Chinese-developed heart valve product in the U.S., the case corroborates not only the unique clinical value of VenusP-Valve™ but also the significance of global-oriented innovation.

Although there are several transcatheter pulmonic valve replacement (TPVR) products available in the U.S. market, such as Melody™ TPV and Harmony™ TPV by Medtronic and the SAPIEN series by Edwards, they do not work for the considerable number of patients with dilated right ventricular outflow tract (RVOT). As a large-diameter product, VenusP-Valve™ can satisfy the clinical needs of 85% of patients in the case of large RVOT. In May 2022, VenusP-Valve™ was approved by the FDA for compassionate use in two patients.

This first patient was a 21-year-old man who suffered from severe pulmonary regurgitation, right ventricular dilation, pulmonary artery dilation, and left ventricular dysfunction after transannular patch (TAP) repair of Tetralogy of Fallot (TOF). The procedure was performed under local anesthesia where the patient remained conscious. Upon preoperative CT, intraoperative contrast-enhanced ultrasound, and balloon measurement, a P34-25 (valve diameter 34mm, straight length 25mm) VenusP-Valve™ that precisely fit the patient's anatomy was delivered through the right femoral vein. On the first postoperative day, ultrasound scan indicated a marked decrease in right ventricle volume with no pulmonary regurgitation. Left ventricular function also returned to normal. Making a sound recovery according to postoperative assessment, the patient was discharged on June 18 (within 24 hours of the procedure) local time.

 "It was a great honor to work with Professor Chen and Professor Feng on the first compassionate use of VenusP-Valve™ in the United States", commented Professor Scott Lim after the procedure. "The product was very easy to handle as it's designed to facilitate precise positioning and delivery. The patient demonstrated significant improvement after the procedure. For the benefit of more patients, I really look forward to formal clinical trials of VenusP-Valve™ here as soon as possible."

Professor Chen congratulated on the first compassionate use of VenusP-Valve™ in the U.S. As he noted, VenusP-Valve™ has gained broad recognition from the global cardiology community since its first implantation in 2013. In particular, the product is a lifesaver for patients with dilated RVOT. Its transcatheter approach reduces trauma and speeds recovery, enhancing quality of life for patients in various dimensions.

Professor Feng said "VenusP-Valve™ is an excellent TPVR product. Its unique double flared-end design enables one-time delivery of stent and valve and simplifies the procedural workflow, making it a powerful tool for transcatheter treatment of pulmonary regurgitation. It is a pride of China to launch such a self-developed innovation in the U.S."

In April 2022, VenusP-Valve™ became the first Chinese-developed self-expanding TPVR product to receive CE marking under the Medical Devices Regulation (MDR). Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, the product is able to meet the needs of 85% of patients. VenusP-Valve™ is also undergoing review and approval with the Chinese National Medical Products Administration (NMPA) and is expected to be marketed within 2022.

During its nine-year clinical use since 2013, VenusP-Valve™ has been applied to nearly 300 cases for humanitarian reasons, spanning 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 UK Medicines and Healthcare products Regulatory Agency (MHRA) for use in designated medical institutions.

VenusP-Valve™ has impressive clinical data backing up its long-term safety and efficacy. According to two-year follow-up result of the clinical study in Europe, the product demonstrated 100% procedural success, with no reoperation or death observed in two years. In addition, moderate and severe pulmonary regurgitation plunged from 16.88% and 83.12% preoperatively to 0%. The data suggest excellent performance, robust safety and reliability, and drastic and steady improvements in patients' cardiac function.

"The first compassionate use of VenusP-Valve™ accentuates the urgent clinical need and high regulatory recognition of the product", said Eric Zi, Founder, Executive Director, and General Manager of Venus Medtech. "VenusP-Valve™ is undergoing clinical trials or marketing application in many mainstream countries. It is an exemplar for Chinese-developed innovative medical devices to reach global markets. We have full confidence in the rapid global launch of the product as well as the benefits it brings to patients worldwide."

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