Medtronic receives early FDA approval for CoreValve System

Medtronic has achieved a key US regulatory milestone for its CoreValve System, which has been approved for sale in Europe since 2007.

The self-expanding transcatheter system has been ratified by the Food and Drug Administration (FDA) for use in the treatment of severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery.

Approval from the FDA was granted ahead of schedule and without any need for an independent device advisory panel review, thanks to exceptional clinical trial data demonstrating its safety and efficacy.

In an extreme risk study, the device was associated with high rates of survival and some of the lowest rates of stroke and valve leakage reported.

Dr John Liddicoat, senior vice-president of Medtronic and president of the company's structural heart business, said: "The FDA approval of CoreValve System is important for US heart teams, as the CoreValve System will serve the broadest spectrum of aortic stenosis patients who are unable to undergo surgery."

Earlier this month, the company agreed a deal to purchase implantable combination antibiotic drug and medical device manufacturer TYRX, thus expanding its capabilities in this area.