Venus Medtech’s VenusP-Valve PROTEUS IDE Pivotal Study Commences

June 14, 2024—Venus Medtech (Hangzhou) Inc. announced the first implantation of its VenusP-Valve transcatheter pulmonic valve replacement (TPVR) system in the PROTEUS investigational device exemption (IDE) pivotal clinical study.

According to the company, the PROTEUS study is evaluating the performance of the VenusP-Valve system in patients with native right ventricular outflow tract (RVOT) dysfunction comorbid with moderate or greater pulmonary regurgitation. The prospective, multicenter, nonrandomized interventional study has a target enrollment of 60 patients.

The initial TPVR procedure in the trial was performed by a multidisciplinary team coordinated by Professor Scott Lim, MD, and Professor Michael Hainstock, MD, at the University of Virginia School of Medicine in Charlottesville, Virginia.

“We’re honored to be part of the VenusP-Valve PROTEUS trial,” commented Prof. Lim in Venus Medtech’s press release. “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.”

Prof. Hainstock added, “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.”

Data from this trial will support VenusP-Valve’s registration with the FDA in the United States and the Pharmaceuticals and Medical Devices Agency in Japan.

The company advised in the press release that in late 2023, the PROTEUS trial received coverage approval from the US Centers for Medicare & Medicaid Services, allowing all eligible beneficiaries to be reimbursed for VenusP-Valve treatment in the study.

In August 2023, the company announced FDA approval of the IDE.

In 2022, the VenusP-Valve received European CE Mark approval under the Medical Devices Regulation in April and it was approved in China in July. Also in 2022, the company announced that the first of two approved compassionate-use cases in the United States were conducted with the device.

The device was developed in-house by Venus Medtech, a China-based provider of transcatheter structural heart valvular therapies, advised the company in the press release.