A further step towards global presence: VenusP-Valve™ approved for compassionate use in two cases in the U.S.
VenusP-ValveTM, Venus Medtech’s in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, recently gained approval from the US Food and Drug Administration (FDA) for compassionate use in two cases. The unique clinical value of VenusP-Valve™ is well proven by the approval prior to formal clinical trials.
Although there are several balloon-expandable or self-expanding TPVR products available in the US market, such as Melody™ TPV and Harmony™ TPV by Medtronic and the SAPIEN series by Edwards, they do not work for a sizable proportion of patients with dilated right ventricular outflow tract (RVOT). In other words, there is an unmet clinical need in such patients that calls for solutions.
The compassionate use application was filed by University of Virginia Advanced Cardiac Valve Center to save two patients with severe pulmonary regurgitation as well as serious complications that add to the difficulty of TPVR. Compassionate use allows patients with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
VenusP-Valve™ is the first-ever Chinese-developed self-expanding TPVR product. Marked by proven clinical value, the product has gained CE marking under the Medical Device Regulation (MDR) in Europe and is under review and approval with the Chinese National Medical Products Administration (NMPA). Uniquely designed with both flared ends, VenusP-Valve™ provides stable anchoring and easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, the product is able to meet the needs of 85% of patients.
Following its first clinical implantation in 2013 by Academician Ge Junbo at Zhongshan Hospital, Fudan University, VenusP-ValveTM has been used in nearly 300 cases for humanitarian reasons, spanning more than 20 countries and regions in Asia, Europe, North America, and South America. In March 2021, VenusP-ValveTM received special use authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for use in designated medical institutions.
VenusP-Valve has impressive clinical data backing up its long-term safety and efficacy. According to two-year follow-up result of the clinical study in Europe, the product demonstrated 100% procedural success, with no reoperation or death observed in two years. In addition, moderate and severe pulmonary regurgitation plunged from 16.88% and 83.12% preoperatively to 0%. The data suggest excellent performance, robust safety and reliability, and drastic and steady improvements in patients’ cardiac function.
“The FDA’s compassionate use approval reflects the urgent clinical need of VenusP-ValveTM and high regulatory recognition of our products”, said Eric Zi, Founder, Executive Director, and General Manager of Venus Medtech. “VenusP-ValveTM is under clinical trials or marketing application in many mainstream countries. It is an exemplar for Chinese-developed innovative medical devices to reach global markets. We have full confidence in the rapid global launch of the product as well as the benefits it brings to patients worldwide.”