Created-in-China VenusP-Valve outperforms international counterpart, say two long-term clinical studies

Recently, two long-term clinical studies of VenusP-Valve transcatheter pulmonic valve system were presented at the Pediatric and Adult Interventional Cardiac Symposium 2021 (PICS-AICS 2021). The first Chinese pulmonic valve developed by Venus Medtech (Hangzhou) Inc. ("Venus Medtech", 2500.HK) showed excellent long-term efficacy and safety and outperformed its overseas counterpart in a number of metrics.

The two studies published by Professor Shakeel Qureshi from Evelina Children’s Hospital in the UK and Professor Zhang Gejun from Fuwai Hospital of the Chinese Academy of Medical Sciences released the 2-year follow-up interim result of the clinical study in Europe (the European study) and 5-year follow-up interim result of a clinical study in China (the Chinese study) respectively.

Data from the European study reported a 100% success rate of TPVR procedures, with no reoperations and deaths observed over 2 years. Moderate pulmonary regurgitation decreased from 16.88% preoperatively to 0% postoperatively, and severe pulmonary regurgitation decreased significantly from 83.12% to 1.54%. The results indicated that VenusP-Valve significantly improved right ventricular function and hemodynamic function, reaching the safety and efficacy endpoints in the trial.

In comparison, the 6-month follow-up data1 of Hamony, the only self-expanding pulmonic valve product marketed worldwide, showed a success rate of 92.9% and a 5% occurrence of moderate pulmonary regurgitation or above. The latter figure of VenusP-Valve over the same period was only 1.35%, showing clear superiority.

Data from the Chinese study reported a 3.64% postoperative 5-year mortality rate. Pulmonary regurgitation was significantly relieved, with severe pulmonary regurgitation decreasing from 54.5% to 0% and moderate-severe pulmonary regurgitation decreasing from 36.4% to 2.22%. In conclusion, VenusP-Valve met its long-term safety and performance endpoints in the Chinese trial as well.

Both Professor Shakeel Qureshi and Professor Zhang Gejun gave high recognition to the long-term clinical outcomes of VenusP-Valve. The two studies testified to the good safety, efficacy and feasibility of the product and its suitability for complex anatomical structures of the pulmonic valve. The researchers looked forward to having it available in the market as soon as possible, so as to benefit more patients.

As one of the core products of Venus Medtech, VenusP-Valve is the world's first self-expanding transcatheter pulmonic valve replacement (TPVR) product developed by a Chinese company and approved for clinical trials in China and Europe. It is also the first product in the world for patients with right ventricular outflow tract disorder (RVOTD) after receiving transannular patch (TAP) treatment.

VenusP-Valve has completed on-site inspection for CE Marking by the European Medicines Agency. The product is expected to be CE certified within the year and become the first self-expanding pulmonic valve approved for marketing in Europe. VenusP-Valve has also been included in the “Special Review and Approval Procedures for Innovative Medical Devices" by the National Medical Products Administration (NMPA), and is expected to be approved within the year. In addition, on March 2021, the product obtained special use authorization from the UK to enter the market in advance.

Eric Zi, Founder, Executive Director and General Manager of Venus Medtech, said, "Venus Medtech has expanded its global footprint with a variety of structural heart products. VenusP-Valve is expected to be another self-developed innovative device approved for marketing in the EU following TriGuard3 Cerebral Embolic Protection Device. We will further advance the clinical trials and market launch of our novel products to bring Chinese innovations to the world and benefit more doctors and patients."

1. PMA P200046: FDA Summary of Safety and Effectiveness Data

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