Clinical trials have shown the VenusP-Valve transcatheter pulmonic valve replacement system to be safe and effective. Credit: Venus Medtech/ PRNewswire.

Health Canada has approved China-based Venus Medtech’s VenusP-Valve transcatheter pulmonic valve replacement (TPVR) system.

Said to be the first self-expanding TPVR product approved in China and Europe, the VenusP-Valve is a Class III implantable cardiovascular device.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The device is designed to ensure blood flow in the branchial artery with bare stents at the outflow end and provide a stable anchoring system without the need for pre-stenting.

Clinical trials have shown the VenusP-Valve to be safe and effective, with a 100% success rate reported in European trials.

The three-year follow-up data indicated no all-cause mortality or reintervention rates, and no moderate or severe pulmonary regurgitation was observed.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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

The VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) in April 2022 and secured investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) last year.

Venus Medtech said that the VenusP-Valve device is now approved in more than 50 countries, including China, Germany, France, the UK, Italy, and Spain.

Hospital for Sick Children in Toronto, Canada cardiac diagnostic and interventional unit director Lee Benson said: “VenusP-Valve is able to eliminate pulmonary regurgitation in a wide range of anatomies.

“Available in different sizes and specifications, the product offers extensive applicability to meet the clinical needs of a larger pulmonary regurgitation patient population.”