Chinese medical technology company Venus Medtech has completed the first implantation of its in-house developed VenusP-Valve transcatheter pulmonic valve replacement (TPVR) system.
VenusP-Valve is the first self-expanding TPVR product approved in China and Europe and is uniquely designed with both flared ends and a stable multi-point anchoring system.
The first-in-human implantation of the TPVR system was performed at the University of Virginia School of Medicine, by a team coordinated by Scott Lim and Michael Hainstock.
It was a part of the PROTEUS IDE clinical study, which evaluated the system in 60 patients with Right Ventricular Outflow Tract (RVOT) disorders comorbid with pulmonary regurgitation.
Venus said that the first procedure significantly advances the progress of VenusP-Valve worldwide and represents a milestone after its CE MDR approval in April 2022.
Scott Lim said: “We’re honoured to be part of the VenusP-Valve PROTEUS trial. We’ve just completed the first patient enrollment in that trial using the VenusP-Valve.
“This worked quite well, and it really represents a possibility of better ways of treating patients with significant pulmonary valve disease.”
Michael Hainstock said: “That went really smoothly in this teenage patient with free pulmonary insufficiency. I’m very happy with the valve deployment and position. This (VenusP-Valve) is another option for our patients to treat pulmonary valve disease.”
The data from the IDE trial would support VenusP-Valve’s registration with the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Last year, the VenusP-Valve PROTEUS trial received coverage approval from the US Centres for Medicare & Medicaid Services (CMS).
It allows all eligible beneficiaries to get reimbursement for VenusP-Valve treatment in the study.
After the first clinical implantation in 2013, the TPVR system has been used in clinical practice for 11 years and included in national health insurance programs in Germany, France, and other countries.
VenusP-Valve has been approved in more than fifty countries, including China, Germany, France, the UK, Italy, Spain, Canada, and Australia.
Venus Medtech general manager and CEO Lim Hou-Sen said: “The successful first implantation in the VenusP-Valve PROTEUS study in the U.S. represents an important milestone for Venus Medtech in this crucial market.
“The device has already received compassionate use approval from the FDA in a number of cases, underscoring its unique clinical advantages and high regulatory recognition. “Moving forward, we will redouble efforts to advance VenusP-Valve’s clinical progress, speeding up its approval process with both the FDA and Japan’s PMDA.”
