Medtronic ($MDT) is inching toward European approval for its Engager heart valve, releasing data demonstrating the device to be safe and effective.
Edwards Lifesciences ($EW) is the market leader for transcatheter aortic valves, and if Medtronic can get the CE mark it desires, it will become one of two options for patients in Europe who cannot sustain traditional open heart procedures, according to MarketWatch.
Medtronic already has a CE mark for CoreValve, but that device isn't cleared for patients with vessels too small to endure arterial implantation, estimated at about 25% of the market. Edwards offers an alternative delivery for its Sapien valve, implanting it through an incision in the chest, making it the only viable device for that patient group.
With Engager, however, Medtronic looks to unseat its rival, and the new data is encouraging. In a study of 60 patients, the valve resulted in no embolisms, no need for repeat procedures and no device malposition. The device, made of bovine tissue leaflets and a self-expanding nitinol frame, recorded a 30-day mortality rate of 9.9% and a stroke rate of 1.8%.
Engager also reduced instances of paravalvular regurgitation, in which blood flows the wrong way through the valve, one of the most common problems with TAVI devices, investigator Hendrik Treede said in a statement. "The Engager valve is a valuable new technology and will allow heart teams to meet the varying needs of patients with severe aortic stenosis," he said.
- read Medtronic's release
- check out the MarketWatch report