Medtronic (NYSE:MDT) said the FDA expanded the approval for its CoreValve transcatheter aortic heart valve to include patients at high risk from open heart surgery.
The CoreValve device was acquired by Medtronic for $700 million plus milestones in 2009.
The device won pre-market approval from the FDA in January for extreme-risk patients.
"It’s rewarding that we can now offer this life-saving therapy to patients at increased risk for surgery," structural heart president Dr. John Liddicoat said in prepared remarks. "There is a lot of excitement among U.S. heart teams for the CoreValve System’s high risk approval, and its unique design that leads to the clinical outcomes seen in the High Risk Trial. We will continue to safely introduce CoreValve System to these physicians, supporting heart teams through comprehensive training and education, imaging and patient evaluation programs."
CoreValve was 1st to market with a TAVI device when it won CE Mark approval in the European Union in 2007, but rival Edwards Lifesciences (NYSE:EW) beat it to the punch in the U.S., winning FDA approval in 2011 for its competing Sapien device. Last month Medtronic agreed to a settlement worth $1 billion to put to rest years of patent infringement lawsuits between the companies.
