Chinese heart valve maker Venus Medtech said today that it launched a clinical trial to support CE Mark approval in the European Union for its Venus P transcatheter pulmonary valve, designed to treat pulmonary regurgitation.
The company said the 1st patient in the trial was implanted last week with the Venus P valve at London’s Evelina Children’s Hospital by Dr. Shakeel Qureshi, principal investigator for the study.
The 1st phase of the trial includes 6 locations and is looking to enroll 80 to 100 patients across Europe, with Venus Medtech touting the trial as the the 1st formal clinical trial at multiple locations in Europe to use a China-made transcatheter valve, according to a press release.
In April, Venus Medtech acquired Regensburg, Germany-based Transcatheter Technologies for an undisclosed amount.
Transcatheter Technologies makes the Trinity transcatheter aortic valve replacement, which it touts as the only TAVR device that’s “truly” repositionable, even after full implantation. Trinity is also designed to minimize or eliminate the paravalvular leakage that’s plagued early TAVR devices, the company has said.
Venus Medtech said it plans to use Transcatheter Technologies portfolio as the basis for the next generation of its TAVR device. The company’s Venus A-Valve has completed the clinical trial phase and is awaiting approval by the China Food & Drug Administration. A transcatheter pulmonary valve replacement is in trials; together, Transcatheter Technologies said, they are expected to be the 1st transcatheter heart valve replacements approved by the People’s Republic.