European regulators have approved the delivery of Medtronic‘s CoreValve System using a new direct aortic approach in patients with severe aortic stenosis.
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.
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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.
