Venus Medtech has announced completion of the first implantation of its VenusP-Valve system in the US as part of the PROTEUS investigational device exemption (IDE) pivotal clinical study.
Conducted at the University of Virginia School of Medicine, the procedure is a significant step in the international expansion of the VenusP-Valve following its CE MDR approval in 2022.
The transcatheter pulmonic valve replacement system targets patients with native right ventricular outflow tract (RVOT) dysfunction and moderate or greater pulmonary regurgitation.
The VenusP-Valve PROTEUS Study is a prospective multi-centre, non-randomised interventional trial in patients with RVOT disorders.
It aims to enrol 60 subjects and will provide data to support the registration of the VenusP-Valve with the US FDA and Japan’s PMDA.
The study received a boost in late 2023 when the US Centers for Medicare & Medicaid Services granted coverage approval, allowing for reimbursement of the VenusP-Valve treatment for eligible beneficiaries.
Since its first clinical implantation in 2013, the VenusP-Valve has been in clinical use for 11 years. It has been integrated into national health insurance programmes in countries including Germany and France.
It is approved in more than 50 countries including the UK, Spain, Italy, Canada and Australia.
Venus Medtech general manager and CEO Lim Hou-Sen said: “The successful first implantation in the VenusP-Valve PROTEUS study in the US represents an important milestone for Venus Medtech in this crucial market.
“The device has already received compassionate use approval from the FDA in a number of cases, underscoring its unique clinical advantages and high regulatory recognition. Moving forward, we will redouble efforts to advance VenusP-Valve’s clinical progress, speeding up its approval process with both the FDA and Japan’s PMDA.”
In February this year, Health Canada approved the VenusP-Valve transcatheter pulmonic valve replacement system.
