China-based Venus Medtech (Hangzhou) has received approval from Health Canada for the VenusP-Valve transcatheter pulmonic valve replacement (TPVR) system.

The company’s in-house developed VenusP-Valve is designed with both flared ends to ensure the blood flow of the branchial artery with bare stents at the outflow end.

The TPVR system is intended to make delivery simple with a stable multi-point anchoring system without the need for pre-stenting before the procedure.

Offered in a range of specifications with extensive applicability, VenusP-Valve can suit the needs of 85% of patients in the case of large right ventricular outflow tract (RVOT), according to Venus Medtech.

The system is said to be the first self-expanding TPVR product approved in China and Europe.

Venus Medtech CEO Lim Hou-Sen said: “Seeking effective treatments for major diseases that pose a serious threat to human health is what we do at Venus Medtech, which makes us proud to have received this Health Canada approval.

“The approval of VenusP-Valve represents a meaningful expansion of clinical options for patients in the country.”

The Chinese firm said that the TPVR system has performed better than similar products in areas like rates of arrhythmia and reintervention while maintaining safety and efficacy.

A European clinical trial’s three-year follow-up data shows that TPVR with VenusP-Valve has a 100% success rate along with zero all-cause mortality and reintervention rates.

Furthermore, there was no evidence of moderate or severe pulmonary regurgitation. In 96.87% of individuals, tricuspid regurgitation, and paravalvular leakage were mild or less.

The results demonstrate superior efficacy, strong safety, and dependability, Venus Medtech added. They also showed steady improvements in patients’ cardiac function.

In April 2022, VenusP-Valve obtained the CE mark under the Medical Devices Regulation (MDR), making it the first Class 3 implantable cardiovascular device authorised under the new MDR.

The self-expanding TPVR product obtained its first ethical approval in the region in 2023 following the receipt of investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA). This approval paved the way for the VenusP-Valve PROTEUS clinical study.