Venus Medtech (Hangzhou) Inc., (HKG: 2500), a leading medical device company, has announced that it has received marketing approval for its VenusP-Valve, a transcatheter pulmonary valve replacement (TPVR) system, in Venezuela. This marks another significant milestone for the company, as VenusP-Valve is the first self-expanding TPVR product to be approved for listing in both Europe and China. In August of the previous year, the product obtained Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA), making it the first domestically produced artificial heart valve to be cleared for clinical trials in the US.
The VenusP-Valve system offers a stable multi-point anchoring system and facilitates easy delivery, eliminating the need for pre-stenting prior to the procedure. The product has since received approvals in over thirty countries, including China, the United Kingdom, Italy, Spain, Denmark, Greece, France, Germany, Poland, Switzerland, and others. The implantations of VenusP-Valve continue to experience growth in new hospitals and centers, highlighting its global acceptance and impact on the medical device industry.- Flcube.com
