The valve replacement system is intended for the use in the treatment of patients with right ventricular outflow tract disorder (RVOTD) following transannular repair
VenusP-Valve secured CE mark under MDR and debuts in Europe as China’s first valve product. (Credit: Venus Medtech (Hangzhou) Inc.)
Chinese medical technology firm Venus Medtech has received authorisation from the European Union (CE) to market its VenusP-Valve system.
The in-house developed VenusP-Valve Percutaneous prosthetic pulmonary valve replacement system matches the safety requirements as per the EU directive, said the company.
The CE mark guarantees its safety features and can be sold now in the EU and other overseas markets.
The valve replacement system is intended for use in the treatment of patients with right ventricular outflow tract disorder (RVOTD) following transannular repair (TAP).
VenusP-Valve can help patients suffering from right ventricular outflow tract blockage for a long period.
In 2011, Venus Medtech announced a partnership with international doctors to jointly develop the VenusP-Valve system.
In September 2016, the firm started CE marking certification pre-market clinical trial in collaboration with Evelina London Children’s Hospital.
At baseline, postoperative clinical findings demonstrate good immediate postoperative outcomes in mild to severe patients.
Venus Medtech said that its VenusP-Valve outperforms other existing similar products in the market in terms of features like a self-expanding valve, and the presence of double-end flared design with multiple anchoring areas to improve the surgery success rate.
In terms of the patient population, it has more product models suitable for more anatomical structures, and the patient coverage rate has been increased from 20% -30% of the ball-expandable valve to approximately 85%.
The company claims that the device can improve the degree of reflux, cardiac function, right ventricular function, and recovery comfort.
Under fluoroscopy, the six golden forming spots can be observed, and the valve may be precisely released; in clinical manifestations, patients getting VenusP-Valve can have predicted symptoms alleviated.
The valve can be released with the help of clear visualisation of six golden developing points.
With self-expanding valve technology, the valve can be easily implanted in the correct position without any technical issues, offering easy recovery for patients.
VenusP-Valve is already used in more than 20 countries, and with the CE mark, it will be available to additional European nations and benefit more people.