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Venusp-Valve released 5-year clinical data, long-term results confirmed

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VENUS MEDTECH wrote a column · Jan 10, 2022 06:37
Venusp-Valve released 5-year clinical data, long-term results confirmed
On January 8, 2022, Hangzhou Qiming Medical Devices Co., Ltd. (“Qiming Medical”, 2500.HK)2021 Chengdu International Valvular Heart Disease Interventional Treatment ConferenceLaunched Venusp-ValveInterim results of a 5-year follow-up trial of a transcatheter artificial pulmonary valve system in China. The data was published by Professor Pan Wenzhi of Academician Ge Junbo's team at Zhongshan Hospital affiliated to Fudan University, the main research unit.
Venusp-Valve released 5-year clinical data, long-term results confirmed
The VenusP-Valve clinical trial in China is an expanded clinical study evaluating the viability, safety, and efficacy of transcatheter artificial pulmonary valve implantation (TPVR) in treating patients with congenital heart disease complicated with severe pulmonary valve reflux with stenosis in the right ventricular outlet. A total of 55 patients were enrolled in the trial, and each was completed at 6 research centers led by Zhongshan Hospital affiliated to Fudan University.
Venusp-Valve released 5-year clinical data, long-term results confirmed
Interim results of the 5-year follow-up showed that the 5-year mortality rate for patients after surgery was only 3.64%. Pulmonary valve regurgitation was drastically reduced, severe pulmonary valve regurgitation was reduced from 54.5% to 0%, and moderate to severe pulmonary valve regurgitation was reduced from 36.4% to 2.22%, which significantly improved right ventricular function and hemodynamic function, fully confirming that VenusP-Valve has reached the end point of long-term safety and performance.
Venusp-Valve released 5-year clinical data, long-term results confirmed
Venusp-Valve released 5-year clinical data, long-term results confirmed
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As one of Qiming Medical's core products, VenusP-Valve is the world's first self-expanding TPVR product developed by a Chinese company and approved for clinical trials in China and Europe. It is also the world's first product for treating patients with right ventricular outflow disorder (RVOTD) after undergoing transvalve ring repair (TAP).
Currently, Venusp-Valve is in the CE certification review stage in Europe, and it is expected to be the first self-inflating pulmonary artery valve approved for marketing in Europe. In March of last year, Venusp-Valve obtained a special use license from the UK Drug Administration and entered the market ahead of schedule. Domestically, the product has been included in the “Special Evaluation Procedure for Innovative Medical Devices” by the China Drug Administration (NMPA), submitted for domestic registration, and accepted by the NMPA.
Venusp-Valve released 5-year clinical data, long-term results confirmed
As the first in China to use Venusp-valve to perform TPVR procedures, it is also the main researcher of this product,Academician Ge JunboHe said, “As early as 2013, we broadcast our first TPVR surgery at the OCC Oriental Conference. The results were good after surgery, and the response was overwhelming. The results of this 5-year follow-up also fully showed that VenusP-Valve has good safety, efficacy, and operability, and is suitable for all kinds of complex pulmonary valve anatomy. We look forward to being approved for marketing as soon as possible, benefiting more patients.”
Venusp-Valve released 5-year clinical data, long-term results confirmed
Founder, Executive Director and General Manager of Qiming HealthcareZi ZhenjunHe said, “Qiming Medical has entered the international market with a number of products targeting structural heart disease. VenusP-Valve is another self-developed innovative device that is expected to be approved and marketed by the European Union after the TriGuard3 anti-embolism remote brain protector. We will continue to promote clinical research and launch of a series of international new technology products to truly promote Chinese innovation globally and benefit doctors and patients.”
Risk Disclaimer: The above content only represents the author's view. It does not represent any position or investment advice of Futu. Futu makes no representation or warranty. Read more
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