Venus Medtech’s VenusP-Valve TPVR Device Treats First Patient in United States in Compassionate Use Procedure

June 22, 2022—Venus Medtech (Hangzhou) Inc., the China-based developer of the VenusP-Valve for transcatheter pulmonary valve replacement (TPVR), announced the completion of the device’s first compassionate use procedure in the United States.

According to the company, the VenusP-Valve is designed with a large diameter to treat patients with dilated right ventricular outflow tract (RVOT), flared ends, and a stable multipoint anchoring system. It enables easy delivery with no need for prestenting before the procedure. The device is intended to ensure blood flow of branchial arteries with bare stents at the outflow end.

The VenusP-Valve TPVR device received European CE Mark approval in April 2022. It is also undergoing review and approval with the Chinese National Medical Products Administration and is expected to be marketed within 2022. In May 2022, the VenusP-Valve was approved by the FDA for compassionate use in two patients.

Professor Scott Lim, MD, performed the procedure with his team at the University of Virginia Advanced Cardiac Valve Center in Charlottesville, Virginia. On-site guidance was provided by Professor Yuan Feng, and remote guidance was provided by Professor Mao Chen. Profs. Feng and Chen are with the Cardiology Department at West China Hospital, Sichuan University in Chengdu, China.

The company reported that this first patient was a male (aged 21 years) experiencing severe pulmonary regurgitation, right ventricular dilation, pulmonary artery dilation, and left ventricular dysfunction after transannular patch repair of Tetralogy of Fallot.

Based on preoperative CT, intraoperative contrast-enhanced ultrasound, and balloon measurement, a P34-25 (valve diameter, 34 mm; straight length, 25 mm) VenusP-Valve that precisely fit the patient’s anatomy was delivered through the right femoral vein. The procedure was performed under local anesthesia where the patient remained conscious.

On the first postoperative day, ultrasound scan indicated a marked decrease in right ventricular volume with no pulmonary regurgitation. Left ventricular function also returned to normal. Making a sound recovery according to postoperative assessment, the patient was discharged on June 18 (within 24 hours of the procedure).

“It was a great honor to work with Professor Chen and Professor Feng on the first compassionate use of VenusP-Valve in the United States,” commented Prof. Lim in the company’s press release. “The product was very easy to handle as it’s designed to facilitate precise positioning and delivery. The patient demonstrated significant improvement after the procedure. For the benefit of more patients, I really look forward to formal clinical trials of VenusP-Valve here as soon as possible.”

Prof. Feng added, “VenusP-Valve is an excellent TPVR product. Its unique double flared–end design enables one-time delivery of stent and valve and simplifies the procedural workflow, making it a powerful tool for transcatheter treatment of pulmonary regurgitation. It is a pride of China to launch such a self-developed innovation in the United States.”