Venus Medtech completes first commercial case of VenusP-Valve™ in Europe
On June 6, 2022, Venus Medtech (Hangzhou) Inc. (2500.HK, hereinafter referred to as "Venus Medtech") announced the first commercial case of VenusP-Valve™ in the UK, an in-house developed novel transcatheter pulmonic valve replacement (TPVR) device of the Company. The case marked another important milestone in the global footprint of Venus Medtech.
The procedure was performed by a multidisciplinary team led by Prof. Dr. James R. Bentham and Prof. Dr. Velasco at Leeds General Infirmary, UK.
The patient was a 25-year-old female with severe pulmonary regurgitation (grade four). The patient received balloon dilation in her infancy (one year old) for treating pulmonary stenosis. Echocardiography showed that the patient's right ventricle was 1.8 times the size of her left ventricle. According to preoperative assessment, the patient's right ventricular ejection fraction (RVEF) was 53%. After receiving a 36mm VenusP-Valve™, the largest size of the product, the patient was cured of pulmonary regurgitation with no perivalvular leakage.
Engineered as an implantable medical device for treating moderate to severe pulmonary regurgitation with or without right ventricular outflow tract (RVOT) stenosis, on April 8, 2022, VenusP-ValveTM became the first Class III implantable cardiovascular device to receive CE marking under the Medical Devices Regulation (MDR). Due to their balloon-expandable design, existing TPVR products in the European market apply to patients with particular anatomic structures only and require pre-stenting. Moreover, these valves come in small diameters and work for 15% to 20% of patients. VenusP-ValveTM on comparison is able to meet the needs of 85% of patients.
“VenusP-Valve™ is available in a range of specifications and provides extensive applicability. The unique design of both flared ends enables stable anchoring and easy delivery”, commented Prof. Dr. James R. Bentham, Consultant Paediatric Cardiologist at Leeds General Infirmary after the procedure.
Prof. Shakeel Qureshi at Evelina London Children's Hospital congratulated Venus Medtech on the first commercial case of VenusP-Valve™ in Europe. “It has been an honor to work on the study for CE registration for VenusP-valveTM. We hope the valve will help patients who would not have been able to be treated.”
“Europe is the bridgehead of Venus Medtech’s international strategy. The successful commercial use of VenusP-Valve™ is a solid step towards our stronger presence in the European market”, said Eric Zi, Co-Founder, Executive Director, and General Manager of Venus Medtech. “We are confident to make Chinese-developed innovative medical devices available to more overseas patients within the next few months. We will step up clinical trials and commercialization of VenusP-ValveTM across global markets, contributing internationally competitive Chinese innovations to the global arena of novel medical devices, delivering even greater benefits to patients.”
VenusP-ValveTM 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 US in 2023, Venus Medtech is preparing for its investigational device exemption (IDE) application to the FDA. In addition, the product was recently approved by the FDA for compassionate use in two cases.