CoreValve was 1st to market with a TAVI device when it won CE Mark approval in the European Union in 2007.
But Edwards beat it to the punch in the U.S., winning FDA approval in 2011 for its competing Sapien device. In May, Medtronic agreed to a settlement worth $1 billion to put to rest years of patent infringement lawsuits between the rivals.
Since the FDA granted approval for the CoreValve device last January, Medtronic has quickly moved to grab a significant stake in the U.S. market for the replacement heart valves, chairman & CEO Omar Ishrak said yesterday.
"The early results have exceeded expectations, as we have been aggressively opening new accounts and have captured over 40% of the U.S. market in just 2 quarters of launching CoreValve," Ishrak told analysts during a conference call to discuss Medtronic’s fiscal 1st-quarter results.
That figure comes with a caveat, however, according to Mike Coyle, president of Medtronic’s cardiac & vascular division.
"We think our overall market share position’s in the low 40s, depending on how you want to treat the royalty income, which our competitor treats as revenue. We tend to exclude it for purposes of that calculation on overall market share," Coyle said. "We basically have been proceeding with the launch as we described. It’s actually a little bit ahead of schedule, in terms of the total number of accounts that have been opened and the training of those accounts, and we actually are getting a little higher share in the accounts we’ve activated than we were expecting."