Global Clinical Trial Commences in Europe for Venus Medtech's Transcatheter Pulmonary Valve

September 19, 2016—Venus Medtech Inc., which is based in Hangzhou, China, announced that the company’s Venus P-Valve, a transcatheter pulmonary valve, was successfully implanted in a European patient, marking the commencement of the clinical trial to support European CE Mark approval for the device. The trial’s Principal Investigator, Prof. Shakeel Qureshi, MD, performed the procedure at Evelina Children's Hospital in London, United Kingdom.

The Venus P-Valve is designed to treat pulmonary regurgitation with or without stenosis in patients.

According to the company, the female patient (27 years of age) had significant pulmonary regurgitation after surgery for tetralogy of Fallot. After implantation of the Venus P-Valve device, the patient showed no signs of the regurgitation, and the valve works well. The patient's vital signs, including blood pressure, have remained within normal ranges since the operation.

The first phase of the European clinical trials will be composed of 80 to 100 patients at six sites across Europe, as well as a few locations outside of the continent. This is the first formal set of clinical trials in multiple locations across Europe that used a China-made transcatheter valve, noted the company.