Medtronic scores CE mark for novel TAVI valve

Medtronic won a CE mark for its Engager aortic valve--courtesy of Medtronic

Medtronic ($MDT) is rapidly boosting its presence in the heart valve market, winning European approval for Engager, a transcatheter aortic valve implantation system to treat patients with aortic stenosis.

The valve, which incorporates cow tissue, is inserted into the heart through a delivery catheter and relieves aortic narrowing in patients at high risk for needing surgical aortic valve replacement. In its pivotal trial, Engager notched a 94.3% success rate, with no embolization, coronary obstruction, device malposition or need for repeat procedures.

Now, Medtronic can challenge Edwards Lifesciences ($EW), the market leader in aortic valves, putting Engager head-to-head with Edwards' Sapien valve in Europe. And Medtronic believes it has the best product available, pointing out that the minimally invasive Engager reduces rates of paravalvular regurgitation--in which blood flows the wrong way through the valve--which is one of the most common complications with TAVI devices.

"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," Medtronic Structural Heart President John Liddicoat said in a statement.

Structural heart is one of Medtronic's smaller units, but its revenues have been on a steady rise. Last quarter, the business brought in $272 million, a 3% increase over the same period the year before, and commercializing Engager in the EU should only pad those numbers.

- read Medtronic's release

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