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Venus Medtech Obtains CE Certification for VenusP-Valve™

IMMEDIAPRESSVenus Medtech Obtains CE Certification for VenusP-Valve™

(Adnkronos) – HANGZHOU, China, April 15, 2022 /PRNewswire/ — On April 8th, a Chinese company named Venus Medtech announced that its self-developed VenusP-Valve™ Percutaneous prosthetic pulmonary valve replacement system was approved by the European Union (CE) for marketing. This shows that VenusP-Valve™ meets the safety requirements stipulated by the EU directive. This product can be sold in the EU and related overseas markets. 

VenusP-Valve™ is the first slef-expanding valve in Europe for the treatment of patients with right ventricular outflow tract disorder (RVOTD) following transannular repair (TAP). Patients who suffer severe right ventricular outflow tract obstruction in a long term can lead to right heart or even total heart failure. These patients require intervention with Percutaneous pulmonary valve replacement. 

In 2011, Venus Medtech invited international doctors to jointly develop VenusP-Valve™. In September 2016, Venus Medtech and Evelina London Children’s Hospital officially launched the VenusP-Valve™ CE marking certification pre-market clinical trial. Postoperative clinical results show excellent immediate postoperative outcomes in moderate to severe patients at baseline. And one-year postoperative results showed all improvement in reflux to less than mild reflux. 88.4% of patients improved NYHA cardiac function to grade I and 11.6% of patients improved to NYHA grade II. 

Compared with other similar products on the market, VenusP-Valve™ has obvious advantages. In terms of patient population, it has more product models suitable for more anatomical structures, and the patient coverage rate has been greatly increased from 20%-30% of the ball-expandable valve to about 85%; in terms of product characteristics, as a self-expanding valve, The double-end flared design with multiple anchoring areas can effectively improve the success rate of surgery. The 6 golden developing points can be clearly visualized under fluoroscopy, and the valve can be accurately released; in clinical manifestations, anticipated symptom of patients receiving VenusP-Valve™ can be relieved. Meanwhile, in the degree of reflux, cardiac function, right ventricular function and recovery convenience have been greatly improved. 

With self-expanding valve technology, the valve is easier to implant in the correct position, there are no technical problems, and the patient recovers well. 

At present, VenusP-Valve™ has been applied in more than 20 countries. It is believed that VenusP-Valve™ will radiate to more countries in the European market and benefit more patients. 

 

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