Medtronic Announces Data From European Pivotal Trial of Engager TAVI System

October 29, 2012—Medtronic, Inc. (Minneapolis, MN) announced data from the Engager European pivotal trial for the investigational Medtronic Engager transcatheter aortic valve implantation system. The Engager uses a transapical delivery approach to treat patients with severe aortic stenosis who were at high or extreme risk for surgical aortic valve replacement. The clinical results were presented during a late-breaking trials session at the European Association for Cardio-Thoracic Surgery annual meeting in Barcelona, Spain.

According to the company, the Engager system was deployed in the anatomically correct position in all 60 patients and demonstrated strong hemodynamic performance with low transvalvular gradients; no patients experienced greater than trace paravalvular leak at 30 days, as measured by an independent echocardiography core lab. Additionally, there were no procedures requiring a second valve, and no occurrences of valve embolization, coronary obstruction, or device malposition. The 30-day all-cause mortality rate was 9.9%, the cardiovascular mortality rate was 8.3%, and the incidence of stroke was 1.8%.

“Results from the European Pivotal Study indicate that the Engager valve's design facilitates precise positioning and reduces paravalvular regurgitation, improving two of the most important clinical challenges faced in transcatheter aortic valve implantation,” commented Engager investigator Hendrik Treede, MD, in the company's press release. “The Engager valve is a valuable new technology and will allow heart teams to meet the varying needs of patients with severe aortic stenosis.”

The Engager transapical valve is comprised of bovine tissue leaflets and a self-expanding nitinol frame designed to aid in valve positioning. The valve is designed to promote annular sealing to minimize paravalvular leak and to provide anatomical alignment with the coronary arteries. The Engager valve is not available for use outside this pivotal trial and is currently being reviewed for CE Mark approval in Europe, advised Medtronic.