This clinical trial, which is likely to enrol 60 patients, will be conducted simultaneously in 10 locations in the US and five centres in Japan, with approvals in both regions expected around 2026
FDA grants IDE approval to VenusP-Valve. (Credit: Robina Weermeijer on Unsplash)
China-based Venus Medtech (Hangzhou) has obtained the Investigational Device Exemption (IDE) full approval from the US Food and Drug Administration (FDA) for the clinical trial of its VenusP-Valve.
VenusP-Valve is a self-expanding transcatheter pulmonary valve replacement (TPVR) product with both flared ends. The product is designed to ensure the blood flow of the branchial artery using bare stents at the outflow end.
The device is now said to be the first Chinese-origin heart valvular system to be cleared by the FDA for a clinical trial.
The IDE approval would enable the VenusP-Valve to begin trials in the US to support the Pre-Market Approval (PMA).
Venus Medtech said that the clinical trial is expected to enrol 60 patients. The trial will be conducted simultaneously in 10 locations in the US and five centres in Japan as part of the Japan-US Harmonization By Doing programme.
The initiative was developed jointly by the FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
The patient enrolment in the US is scheduled for the second half of this year and in Japan in early 2024, with approvals in both regions expected around 2026.
Venus Medtech, a transcatheter structural heart valvular therapies provider, said that the VenusP-Valve was used in two cases for compassionate usage in the US in 2022.
Venus Medtech co-founder, executive director, and general manager Eric Zi 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 enrollment and the collection of clinical follow-up results, leading to its marketing approval in the US.”
In April last year, VenusP-Valve secured CE marking under the Medical Devices Regulation (MDR). It was claimed as the first Class 3 implantable cardiovascular device approved under the new MDR.
The heart valvular system has already been approved in over 30 countries, including China, the UK, Denmark, Greece, Italy, Spain, Germany, France, Poland, and Switzerland.