Venus Medtech receives Best Outbound Practice Awards – Innovative Medical Device 2022
Venus Medtech received Best Outbound Practice Awards – Innovative Medical Device for VenusP-ValveTM transcatheter pulmonic valve replacement system’s enhanced presence in European and American markets at the recent 2022 China Medical Device Outbound Conference. Awardees of the prize also include United Imaging Healthcare and Haier Biomedical.
The conference was organized by the International Health Exchange and Cooperation Center of the National Health Commission and VBData VB100 and received extensive support from diplomatic missions in China. The criteria for Best Outbound Practice Awards look at novelty, clinical advantages, and impact. Eventually, twelve devices were selected for Best Outbound Practice Awards - Innovative Medical Device.
In April 2022, VenusP-ValveTM, Venus Medtech's in-house developed innovative TPVR system, received CE marking under the Medical Devices Regulation (MDR) in the EU. The approval ushered in a new chapter for Chinese-made valve products in the market, marking a new milestone in the global presence of China’s innovative medical devices. In May, VenusP-ValveTM was approved by the US Food and Drug Administration (FDA) for compassionate use in two cases – both have been successfully completed at Advanced Cardiac Valve Center, University of Virginia. Then in June, the device completed its first commercial application in the UK.
The device’s novelty lies not only in its design, but also in the approaches it pioneered to conduct overseas clinical trials and advance registration. Apart from showing China’s growing ability to create innovative products, the outbound practice of VenusP-ValveTM sets a model for the industry. It boosts the confidence of China’s medtech industry and moves the country one step closer to its vision as an innovation powerhouse.
VenusP-ValveTM was the first Class III implantable cardiovascular device approved under the new MDR. There was no CE MDR certificate issued to any Class III implantable cardiovascular device until VenusP-ValveTM.
In addition, the Investigator Meeting for VenusP-ValveTM U.S. Clinical Study was held during Catheter Interventions in Congenital, Structural and Valvular Heart Disease (CSI) 2022, a key milestone before starting clinical trials in the U.S. Noteworthily, the trials are expected to launch concurrently in the U.S. and Japan, accelerating device registration in both countries, thereby making VenusP-ValveTM a truly global product.
By virtue of the overseas launch of VenusP-ValveTM, Venus Medtech reported RMB 14 million in overseas sales in H1 2022, a sharp year-on-year increase of 150.9%. In specific, VenusP-ValveTM generated RMB 9 million in sales in only two months, demonstrating huge potential in overseas markets.
Committed to global-oriented innovation, Venus Medtech will continue to work on unprecedented, groundbreaking technologies in China and beyond, bringing “created in China” to the world.