Medtronic receive CE Mark for Engager Transcatheter Valve

Medtronic has been granted European CE Mark approval for its new Engager Transcatheter Aortic Valve Implantation System for the treatment of aortic stenosis.

The device features a  transapical delivery catheter and is designed for the treatment of patients with severe aortic stenosis who are at high or extreme risk for surgical aortic valve replacement.

In a European pivotal trial, it was shown that the system was associated with high rates of procedural success, minimal paravalvular leakage and continuing clinical benefits for patients over time.

A direct aortic delivery system for Engager will also be introduced in the future by Medtronic.

Dr John Liddicoat, senior vice-president and president of Medtronic's structural heart business, said: "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."

The company also announced this week that it received regulatory approval to update the CE Mark labeling for its Resolute Integrity drug-eluting stent with new information on dual antiplatelet therapy.