Venus Medtech Reports First Implantation of the VenusP-Valve in its Pivotal Trial Across the US
Shots:
- Venus Medtech has reported the first implantation of its transcatheter pulmonic valve replacement (TPVR) system, VenusP-Valve, in the IDE pivotal clinical evaluation (PROTEUS) at the University of Virginia School of Medicine
- The PROTEUS study assesses the safety & effectiveness of the VenusP-Valve system among patients (n=60) with native right ventricular outflow tract dysfunction. The results will form the basis of registration with the US FDA and Japanese PMDA
- The system’s European study results demonstrated a 100% success rate in the 3yrs. follow-up and 0 all-cause mortality with 81 patients having reoperation post TPVR plus improvement in right ventricular function. However, 1 case of severe pulmonary regurgitation was reported
Ref: Venus Medtech | Image: Venus Medtech
Related News:- Venus Medtech’s VenusP-Valve System Receives Health Canada’s Approval
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
