FDA Rejects Medtronic Device for Atrial Fibrillation Treatment
A Food and Drug Administration (FDA) panel rejected an experimental catheter intended for use in the treatment of atrial fibrillation, saying the device’s potential risks outweighed its benefits.
Atrial fibrillation is characterized by a rapid, irregular heart rate and is a leading contributor to strokes. The catheter, made by Medtronic, uses radio frequency and heat to vaporize the heart tissue causing an abnormal heartbeat.
The panel indicated that the medical device is effective in principle, but still needed safety enhancements. Citing clinical trials of the device, the panel also expressed concern that women did not respond as well to the catheter treatment as men.
Medtronic can seek approval for the device again after further refinement and clinical trials.
Meanwhile, Medtronic is facing an increasing number of personal injury lawsuits over its InFuse bone graft device, which delivers a protein intended to stimulate bone growth and was approved for use in some back surgeries. However, reports are increasing of side-effects including excessive bone growth, pain and respiratory problems among other complications.
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