Medtronic has announced European clearance of the Engager transcatheter aortic valve, a prosthetic delivered via a transapical catheter for the treatment of severe aortic stenosis in patients not suitable for surgical valve replacement.
The approval comes thanks to the Engager European Pivotal Trial the results of which Medtronic proudly publicized last October. The device was originally developed by Ventor Technologies, a company later purchased by Medtronic, and is composed of a nitinol frame and bovine tissue leaflets.
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.
Press release: Medtronic Announces CE Mark for Engager™ Transcatheter Valve