Medtronic, Inc. (Medtronic), is planning to complete the trial entitled “Catheter-Based Transapical Implantation of the Ventor Embracer Heart Valve Prosthesis in Patients With Severe Aortic Valve Disease” for the product Ventor Embracer by June 2014. The purpose of the study is to evaluate feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer aortic valve bioprosthesis. The study is for patients with severe aortic valve disease, specifically aortic stenosis, who are at elevated risk for standard surgical valve replacement. The study is being conducted in Germany.
The prospective single arm, open label study currently recruiting approximately 30 participants. The principal investigators are Jochen Schaefers, MD from Universitatsklinikum des Saarlandes and Friedrich Mohr, MD from Universitat Leipzig.
Ventor Embracer Aortic valve prosthesis is a novel aortic valve prosthesis for catheter-based, beating heart implantation in patients with aortic Stenosis. Its valve design combines safe, quick and intuitive delivery, with hemodynamic performance as well as a structure which ensures long-term durability. It allows catheter-based aortic valve replacement to become the therapy of choice in the majority of patients with aortic stenosis who need intervention. It is implanted safely, quickly and intuitively.