Medtronic announced the first results from a European multi-center trial of the Engager Transcatheter Aortic Valve Implantation (TAVI) System, a transapicaly delivered implant for treatment of severe aortic stenosis.
Originally developed by Ventor Technologies, a company that was purchased by Medtronic, the Engager is meant for use on patients who are not candidates for open heart surgery. It is composed of a nitinol frame and bovine tissue leaves, and works to self-align during implantation to prevent leaks.
Results from the Engager European Pivotal Trial:
The positive clinical outcomes, presented during a late-breaking trials session at the European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting, revealed that the Engager system was deployed in the anatomically correct position in all 60 patients. The Engager valve demonstrated strong hemodynamic performance with low transvalvular gradients, and no patients experienced greater than trace paravalvular leak at 30 days as measured by an independent echocardiography core lab. 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 percent, the cardiovascular mortality rate was 8.3 percent, and the incidence of stroke was 1.8 percent.
“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. The Engager valve is a valuable new technology and will allow heart teams to meet the varying needs of patients with severe aortic stenosis,” said Hendrik Treede, M.D., Engager Pivotal Trial investigator, University Heart Center Hamburg in Hamburg, Germany.
Related: Video (in Hebrew with slides in English) of Ehud Schwammenthal, MD, PhD, Associate Professor of Cardiology at Sheba Medical Center in Ramat Gan, Israel and Dr. Guy Ezekiel talking about the development of the valve (2 hour run time):