An FDA panel voted 9-2 against recommending approval for Medtronic’s implantable monitoring device for heart failure. Although I’m sure Medtronic is disappointed in the result, no one was really surprised. After all the device had failed to demonstrate efficacy –in a trial whose results were two years ago (although spun positively at the time) — even though the device was shown to be safe. Medtronic seems to have underestimated the number of patients needed to provide sufficient statistical power –so it’s quite possible that a larger trial would have shown efficacy.
Monitoring is a tricky topic. It seems like a great idea to gather objective data from patients to spot concerns before they become crises. On the other hand someone has to act on that data. Doctors aren’t always set up to do so.
Chronicle had an additional hurdle over traditional external heart monitoring devices: the need for surgery to implant it. The presumed benefits of improved compliance and better data have to be weighed against surgery risk.
But all is not lost for Chronicle. A version of Chronicle that includes an Implanted Cardiac Defibrillator (ICD) is currently undergoing testing. That trial, which has about 850 patients, is likely to conclude this year. Most ICD patients have heart failure, so Medtronic may find a sizable market for the combo device. Better yet for Medtronic, competitors appear to be at least a year behind.March 2, 2007