Medtronic, Inc. MDT 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.
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