Medtronic's Engager TAVI Device Receives CE Mark Approval

February 28, 2013—Medtronic, Inc. (Minneapolis, MN) announced CE Mark approval of the Engager transcatheter aortic valve implantation (TAVI) system with a transapical delivery catheter to treat patients with severe aortic stenosis who are at high or extreme risk for surgical aortic valve replacement. Medtronic advised that the Engager system is not available in the United States.

According to Medtronic, the Engager valve uses a transcatheter delivery system that is inserted in the apex of the heart. The valve is composed of bovine tissue leaflets and a self-expanding nitinol frame designed to promote annular sealing to minimize paravalvular leak (PVL). Control arms simplify implantation, and the supra-annular valve positioning facilitates leaflet coaptation in noncircular anatomy for optimal hemodynamic performance. Medtronic noted that a direct aortic delivery system for Engager will be introduced in the future.

In its press release, the company stated that the new valve demonstrated positive clinical outcomes in its European pivotal trial. The clinical results from the multicenter trial were first presented in October at the European Association for Cardio-Thoracic Surgery annual meeting in Barcelona, Spain, and were also presented in January 2013 at the annual meeting of the Society of Thoracic Surgeons in Los Angeles. The data revealed high rates of procedural success, minimal PVL, and continuing clinical benefits for patients over time.

Medtronic reported that in the trial, the Engager valve was delivered transapically and had 94.3% overall device success (according to Valve Academic Research Consortium modified definitions). There were no procedures requiring a second valve and no occurrences of valve embolization, coronary obstruction, or device malposition. No patients had moderate or severe PVL at 6 months, as measured by an independent echocardiography core lab. In addition, while most patients (88%) were NYHA Class III or IV at baseline, at 6 months 82% of patients had improved to NYHA Class I or II.