Transcatheter Aortic Valve is CE Cleared
Published date : 04 March 2013
Article date : 04 March 2013
Medgadget reports that Medtronic's Engager transcatheter aortic valve, a prosthetic delivered via a transapical catheter for the treatment of severe aortic stenosis in patients who are unsuitable for surgical valve replacement, has gained CE approval.
The valve is composed of a nitinol frame and bovine tissue leaflets. CE clearance follows the Engager European multi-centre pivotal trial, the results of which revealed high rates of procedural success, minimal paravalvular leak (PVL) and continuing clinical benefits for patients over time.
They say that 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.
Source: Gene Ostrovsky, Medgadget, 01 March 2013
