Venus Medtech has announced US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for its VenusP-Valve percutaneous pulmonary valve system.
The device becomes the first Chinese-developed heart valve system to be approved by the FDA for a clinical trial, “setting a new milestone in the global footprint of Chinese valves,” the company says in a press release.
The IDE approval will allow VenusP-Valve to initiate pivotal clinical trials in the USA to support premarket approval (PMA). Through the Japan-US Harmonization By Doing programme, jointly established by the FDA and Japan’s Pharmaceutical and Medical Device Agency (PMDA), the clinical trial will be conducted concurrently at 10 centres in the USA and five centres in Japan, with 60 patients expected to be enrolled.
The device is set to enrol patients in the USA in the second half of this year and in Japan in early 2024, with approvals expected around 2026 in both markets.
Eric Zi, co-founder, executive director and general manager of Venus Medtech, said: “The approval of VenusP-Valve’s IDE marks a significant milestone in our global strategy and showcases the team’s unwavering dedication to progress and innovation. As our innovative products enter the phase of fruition one after another, we anticipate 2026 as a year of substantial growth in global expansion. We excitedly look forward to VenusP-Valve’s prompt patient enrolment and the collection of clinical follow-up results, leading to its marketing approval in the USA.”
VenusP-Valve has been used in two compassionate-use cases in the USA, and received the CE mark under the European Medical Devices Regulation (MDR) in April 2022.
