CE mark for Engager TAVI system


Medtronic has announced that, following CE mark approval, its Engager transcatheter aortic valve implantation (TAVI) system can now be used in patients with severe aortic stenosis who are high or extreme risk of surgery.

According to a company press release, the new valve demonstrated positive clinical outcomes in its European pivotal trial. The press release explained that results from the multicentre 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 and continuing clinical benefits for patients over time.


In the trial, the Engager valve was delivered transapically and had a 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 embolisation, coronary obstruction or device malposition. No patients had moderate or severe paravalvular at six months, as measured by an independent echocardiography core lab. In addition, while most patients (88%) were New York Heart Association (NYHA) class III or IV at baseline, 82% of patients had improved to NYHA Class I or II at six months.


“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,” said John Liddicoat, senior vice president of Medtronic and president of the Medtronic Structural Heart Business.