- Medtronic (MDT +0.4%) says it received FDA approval, three months earlier than expected, to sell its CoreValve heart valve technology for patients too frail for traditional surgery approval.
- The approval allows MDT to begin competing against Edwards Lifesciences (EW -5.1%), whose similar Sapien device has been approved for a wider range of patients, including those who are eligible for surgery, but who are considered at high risk for complications.
- CoreValve is approved for patients with severe aortic stenosis who are too sick or frail to undergo open-heart surgery; in a clinical trial, patients receiving the device had a 25% rate of death or major stroke after one year vs. an estimated rate of 43% had the patients received medication therapy.
FDA approves Medtronic heart valve system early
Jan 17 2014, 14:10 ET