Venus Medtech Achieves First U.S. Implantation of VenusP-Valve in IDE Pivotal Study

Saturday, June 15, 2024

Venus Medtech, a prominent provider of transcatheter structural heart valvular therapies in China, has announced a major milestone. The company’s innovative transcatheter pulmonic valve replacement (TPVR) system.

VenusP-Valve, has successfully completed its first implantation as part of the PROTEUS IDE Pivotal Clinical Study at the University of Virginia School of Medicine.

This significant procedure was carried out by a multidisciplinary team led, furthering the international progress of VenusP-Valve after its CE MDR approval in April 2022.

The VenusP-Valve PROTEUS STUDY (Evaluation of the Performance of the VenusP-Valve System in Patients with Native Right Ventricular Outflow Tract [RVOT] Dysfunction) is a prospective, multi-center, non-randomized interventional study involving patients with RVOT disorders and moderate or greater pulmonary regurgitation.

The study aims to enroll 60 subjects, with data supporting VenusP-Valve’s registration with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

In late 2023, the trial gained coverage approval from the U.S. Centers for Medicare & Medicaid Services (CMS), ensuring reimbursement for eligible beneficiaries.

Since its first clinical use in 2013, VenusP-Valve has been included in national health insurance programs in several countries, including Germany and France, and has been approved in over fifty countries such as China, Germany, France, the UK, Italy, Spain, Canada, and Australia. The device continues to be adopted by more hospitals and centers.

“We're honored to participate in the VenusP-Valve PROTEUS trial,” stated Prof. Scott Lim. “Completing the first patient enrollment in this trial with the VenusP-Valve is promising for treating significant pulmonary valve disease.”

"The procedure went smoothly in this teenage patient with pulmonary insufficiency. The valve deployment and position were excellent. VenusP-Valve is a valuable new option for treating pulmonary valve disease.”

“The successful first implantation in the U.S. PROTEUS study is a significant milestone for Venus Medtech. The VenusP-Valve has received compassionate use approval from the FDA in various cases, underscoring its clinical advantages.

We will continue to advance its clinical progress and expedite its approval process with the FDA and Japan’s PMDA.”

The VenusP-Valve, the first self-expanding TPVR product approved in China and Europe, is noted for its clinical significance. Its unique design features flared ends and bare stents at the outflow end, ensuring proper blood flow in the branchial artery and providing a stable multi-point anchoring system.

The device is easy to deliver without pre-stenting and is available in various specifications to meet the needs of 85% of patients with large RVOT.

Long-term safety and efficacy of VenusP-Valve are supported by clinical data. A three-year follow-up of a European clinical trial showed 100% procedural success, 0% all-cause mortality, and no reoperations among 81 patients, with significant improvement in right ventricular function and only one case of severe pulmonary regurgitation.