VenusP-Valve obtains special use authorization in UK to enter the market in advance
On March 22, Venus Medtech (Hangzhou) Inc. (hereinafter referred to as "Venus Medtech", 2500.HK), a leading provider of integrated solutions for transcatheter heart valve disease treatment in China, announced that its core product VenusP-Valve, a transcatheter pulmonic valve system, received special use authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom for use in designated medical institutions.
Authorization of special use is granted to medical products that are clinically urgent with no similar products available in the market. Under the UK Medical Devices Regulations, non-CE marked medical devices are allowed to be used in designated hospitals for a given period to protect public health on humanitarian grounds. We submitted the application for the CE Marking in 2019 and it is currently under review. This special use authorization means that VenusP-Valve has entered the UK market before obtaining the CE marking.
VenusP-Valve is the world's first China-developed self-expanding transcatheter pulmonary valve replacement (TPVR) product approved for clinical trials in China and Europe. It is also the first TPVR product for patients with right ventricular outflow tract disorder (RVOTD) after receiving transannular patch (TAP) treatment globally. Prolonged severe RVOTD can lead to right-sided heart failure or even total heart failure, significantly shortening the survival of patients. Therefore, proper treatment is needed.
According to Frost & Sullivan, the population of patient with RVOTD will rise to 127,700 worldwide by 2025, a compound annual growth rate of over 7%. Compared with the marketed balloon-expandable TPVR products, VenusP-Valve has a wider range of specifications and is more suitable for patients with excessive dilation of right ventricular outflow tract, without the use of stents and valvuloplasty balloons.