Venus Medtech’s VenusP-Valve Receives IDE Approval for Pivotal Trial in United States and Japan

August 6, 2023—Venus Medtech (Hangzhou) Inc., a China-based provider of transcatheter structural heart valve therapies, announced FDA approval of an investigational device exemption (IDE) for the company’s in-house developed VenusP-Valve for transcatheter pulmonary valve replacement.

The IDE approval will allow the company to initiate a pivotal clinical trial to support the premarket approval submission of the VenusP-Valve. This clinical trial will be conducted concurrently at 10 centers in the United States and five centers in Japan through the Japan-United States Harmonization By Doing program.

The trial, which is expected to enroll 60 patients, will commence in the United States in the second half of 2023 and in Japan in early 2024. Approvals are expected approximately in 2026 in both markets.

In June 2022, the company announced that the first of two approved compassionate-use cases in the United States were conducted with the VenusP-Valve.

Also in 2022, the device received European CE Mark approval under the Medical Devices Regulation in April and it was approved in China in July.