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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