Chinese heart valve maker Venus Medtech said today it launched its Venus P-Valve self-expanding pulmonary valve implant in Canada, touting that the first procedures with the valve have been performed in the region.
The Venus P-Valve was designed for percutaneous use in native right ventricular outflow tracts, the Hangzhou-baesd company said, and is intended for patients who wish to avoid sternotomy and cardiopulmonary bypasses associated with traditional valve replacement surgeries.
The first procedures were performed on two patients who had previously been treated with surgical patch correction for tetralogy of Fallot, Venus said.
“The VenusP-Valve performed beautifully and has a simple to operate delivery system. We are very happy to have this device in our center, and we look forward to having it widely available in Canada,” Dr. Ronald Carere of Canada’s St. Paul’s Hospital, who was part of the team that used the Venus P-Valve in its first procedures, said in a press release.
The company touted that the use was the first of its kind for the valve in North America, and that it intends to launch an FDA clinical trial next year.
In May, Venus Medtech said it inked a partnership deal with Keystone Heart through which Venus will gain exclusive rights to develop and sell a third-gen version of Keystone’s TriGuard 3 device in China and other Asian markets.