The AP reports, “Medtronic Inc. says a panel advising the US 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 Wall Street Journal reports the advisory panel voted 8-2 stating the risks of the device outweighed its benefits to treat patients with atrial fibrillation.
Bloomberg News reports the panel “voted 10-0 that Medtronic’s so-called ablation system is effective” but “they decided 9-1 that it isn’t safe for patients who experience the heart ailment for long periods of time and need intervention.” David Steinhaus, medical director in Medtronic’s cardiac rhythm disease management division said, “‘We need to go back and decide how we can best’ address safety issues.”
Reuters reports the company enrolled 176 patients into their clinical trial. However, 5 study participants experienced a stroke within a month of treatment and 38 patients had a serious adverse event, according to the FDA.
From the American Association for Justice news release.
