Hangzhou, China-based Venus Medtech has received CE mark certification for its VenusP-Valve, its transcatheter pulmonic valve-replacement system.

The device is for the treatment of patients with moderate-to-severe pulmonary regurgitation, with or without right-ventricular outflow tract stenosis.

The valve, which is available in several sizes, features flared ends that provide stable anchoring, with no need for pre-stenting before the procedure

Since its first clinical implantation in 2013, the valve has been used in nearly 300 cases in more than 20 countries, the company said.  In March 2021, it received a special use authorization from the UK’s Medicines and Healthcare products Regulatory Agency.