Venus Medtech has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct a clinical trial for the VenusP-Valve.
The approval will enable the company to start pivotal clinical studies of the device in the US to support the pre-market approval.
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Under the Japan-US Harmonization By Doing programme, a collaborative effort between the FDA and Japan’s PMDA (Pharmaceuticals and Medical Devices Agency), the trials are set to take place simultaneously at ten centres in the US and five Japanese centres.
Expected to enrol 60 patients, the trials will begin in the US in the second half of this year and Japan early next year.
The company is anticipating approvals for the device in both markets in 2026.
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 enrolment and the collection of clinical follow-up results, leading to its marketing approval in the US.”
In April last year, the company received the CE mark under the Medical Devices Regulation for the Class III implantable cardiovascular device.
The device has so far received approval in more than 30 countries, including Denmark, France, Germany, Greece, Italy, Poland, Spain, Switzerland and the UK.
