Call Us - We're Easy to Talk To (214) 999-9999

FDA Advisory Panel Says Medtronic Catheter’s Risks Outweigh Benefits

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.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

About This Blog

The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

If you find this type of information interesting or helpful, please visit my law firm's main website at You will find many more articles and links. Thank you for your time.

Find us on your preferred network