Medtronic Reports CE Mark for Engager Transcatheter

Medtronic, Inc.

today announced CE (Conformité Européenne) Mark of the Engager Transcatheter Aortic Valve Implantation (TAVI) System with transapical delivery catheter to treat patients with severe aortic stenosis who are at high or extreme risk for surgical aortic valve replacement (SAVR). The new valve demonstrated positive clinical outcomes in its European Pivotal Trial. Results from the multi-center trial, which were presented during late-breaking trial sessions at the recent European Association for Cardio-Thoracic Surgery and the Society of Thoracic Surgeons annual meetings, revealed high rates of procedural success, minimal paravalvular leak (PVL) and continuing clinical benefits for patients over time. In the Trial, the Engager valve was delivered transapically and had 94.3 percent 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 six months, as measured by an independent echocardiography core lab. In addition, while most patients (88 percent) were NYHA Class III or IV at baseline, at six months 82 percent of patients had improved to NYHA Class I or II.