Medtronic: FDA panel rejects heart catheter
Go Deeper.
Create an account or log in to save stories.
Like this?
Thanks for liking this story! We have added it to a list of your favorite stories.
Medtronic Inc. says a panel advising the U.S. Food and Drug Administration has concluded that an experimental catheter from the medical device maker poses a potential health risk that outweighs its benefit to patients.
The company is asking the FDA to approve the device for atrial fibrillation, which causes the heart's upper chambers beat rapidly and ineffectively.
The catheter uses extreme heat to correct irregular heartbeats.
Medtronic said Thursday that the FDA's Circulatory Systems Devices advisory panel voted against the device.
It said a majority of the panel's members concluded from clinical trial data that there isn't a reasonable assurance that the catheter is safe to use.
The panel's recommendation isn't binding, but will be considered by the FDA when it reviews Medtronic's request to bring the device to market.
(Copyright 2011 by The Associated Press. All Rights Reserved.)
Turn Up Your Support
MPR News helps you turn down the noise and build shared understanding. Turn up your support for this public resource and keep trusted journalism accessible to all.