Venus Medtech announced today that study investigators completed the first implant of its transcatheter pulmonic valve replacement (TPVR) system.
A University of Virginia School of Medicine team completed the first implant in the PROTEUS FDA investigational device exemption (IDE) pivotal trial. Investigators reported a smooth procedure in a teenage patient with free pulmonary insufficiency.
The company said in a news release that it marks the latest advancement for the VenusP-Valve, which received CE mark in 2022.
PROTEUS evaluates patients with right ventricular outflow tract (RVOT) disorders comorbid with moderate or greater pulmonary regurgitation. Venus targets an enrollment of 60 patients and hopes the data supports its regulatory submissions in the U.S. and Japan.
Late last year, the Hangzhou, China–based company also received Medicare coverage for the PROTEUS trial. Coverage enabled reimbursement for eligible beneficiaries in the valve study.
“The successful first implantation in the VenusP-Valve PROTEUS study in the U.S. represents an important milestone for Venus Medtech in this crucial market,” said Lim Hou-Sen, GM and CEO of Venus Medtech. “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.”
