Transcatheter aortic valve implantation (TAVI) is a less-invasive alternative to open-heart surgery for aortic valve replacement, but some patients are unsuited for the procedure because they have small vessels. The newly CE Marked direct aortic approach provides a minimally invasive option for those patients.
In the procedure, physicians replace the diseased valve through a small incision without stopping the heart or penetrating its ventricular wall.
CoreValve is part of Medtronic’s CardioVascular business, which accounted for 18 percent of the company’s overall revenue in fiscal year 2010. Another new product in the CoreValve line — the world’s largest transcatheter aortic valve — received the CE Mark in August.
About 300,000 people globally have been diagnosed with severe aortic stenosis, and 100,000 of them are too high risk for open-heart surgery, Medtronic said in a statement.
The CoreValve system is still limited to investigational use in the U.S.; Medtronic began a U.S. pivotal study of CoreValve in its third fiscal quarter of 2011. But Edwards Lifescience beat Medtronic in the U.S. — its Sapien Transcatheter Heart Valve was cleared by the U.S. Food and Drug Administration last week. Medtronic, meanwhile, is eyeing a U.S. launch for CoreValve in 2014.