First North American Clinical Implantation of Venus Medtech's VenusP-Valve Performed in Canada
June 18, 2018—Venus Medtech Inc. announced the completion of the first two implantations in Canada of the VenusP-Valve self-expanding pulmonary valve device. The procedures, which were performed at St. Paul 's Hospital in Vancouver, British Columbia, mark the device's entry into the North American market.
The company is expected to begin a US Food and Drug Administration clinical trial in 2019. Additionally, the upcoming VenusP-Valve global multicenter clinical trial has received more than 200 applications from approximately 30 countries worldwide.
According to Venus Medtech, the self-expanding VenusP-valve has been developed specifically for percutaneous use in the native right ventricular outflow tract to overcome the challenge of the larger outflow tracts and can fulfill the needs of more than 85% of patients who want to avoid sternotomy and cardiopulmonary bypass during traditional valve replacement surgery.
The procedures in Vancouver were performed on two patients who were previously treated with surgical patch correction for tetralogy of Fallot. The interventionalists reported that these patients were more at risk of reventriculotomy, and currently available transcatheter pulmonary valve products were not suitable for these cases. The VenusP-Valve was selected as the most suitable device to serve this need.
Ronald G. Carere, MD, who performed the procedures with Mounir Riahi, MD, at St. Paul 's Hospital, commented in the company's announcement, "The VenusP-Valve performed beautifully and has a simple-to-operate delivery system. We are very happy to have this device in our center, and we look forward to having it widely available in Canada."