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Medtronic, Inc. (MDT) Receives CE Mark for Engager Transcatheter Valve
3/7/2013 9:21:56 AM
Officials from Minneapolis, Minn.-based Medtronic Inc. announce 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% 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%) were NYHA Class III or IV at baseline, at six months 82% of patients had improved to NYHA Class I or II. "The Engager valve has demonstrated exceptional clinical results, and by adding it to our transcatheter valve portfolio, we are providing heart teams with more options for achieving the best outcomes for every patient with severe aortic stenosis," states John Liddicoat, M.D., senior vice president, Medtronic, and president, the Medtronic Structural Heart Business.
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