The Fridley, Minn.-based medical device giant said patients in Denmark were the first to undergo surgery in the 2,500-patient trial.
Medtronic acquired CoreValve for more than $1 billion in 2009 and is chasing Edwards Lifesciences (NYSE:EW), which was 1st to market with its Sapien transcatheter aortic valve implant. The company said the study will be the largest investigation to date comparing TAVI with open heart surgery.
"Medtronic is working with the U.S. Food & Drug Administration to include U.S. patients in the trial," according to a press release.
The CoreValve TAVI system won CE Mark approval in the European Union in March 2007 and is expected to hit the U.S. market in 2014. Edwards’ Sapein TAVI device was approved for the U.S. market last year. Boston Scientific (NYSE:BSX) is also in the running with its Lotus TAVI.