FDA Panel Gives Medtronic Cardiac Ablation System a Thumbs Down

A panel of outside medical experts has recommended that federal regulators not approve a cardiac ablation system to treat atrial fibrillation being developed by Medtronic, Inc.

According to a report from The Wall Street Journal, members of a U.S. Food & Drug Administration (FDA) advisory panel voted 8-to-2 against a question that asked if benefits of the device, known as the Phased RF Ablation System, outweighed the risks. The Circulatory System Devices advisory panel did agree unanimously that the Medtronic ablation device was effective, but voted 9 to 1 that the data do not provide reasonable assurance about its safety.

The Phased RF Ablation System uses catheter ablation, which involves inserting a thin tube into a blood vessel, usually through a site in the upper leg or neck, then threading it though the body until it reaches the heart. Radio frequency energy is then used to heat cardiac tissue to reroute electrical signals in the heart, the Journal said. While there are catheters on the market to treat atrial fibrillation, Medtronic’s device would be the first approved for the persistent form of the disease.

According to the Journal, ablation devices were originally designed and FDA approved to burn or destroy tissue in order to stop bleeding. Doctors later discovered they could burn a maze-like pattern in the heart in order to reroute the electrical system to treat atrial fibrillation. Such devices, though not specific approved to treat the condition, are being used to treat atrial fibrillation, but usually during other heart surgeries, such as valve replacement.

Earlier this week, FDA staff voiced concerns about the Medtronic system, after 21 percent of patients who were treated with the device experienced a serious side effect, including stroke, heart failure and pneumonia. However, 56 percent with the catheter saw improvement of their symptoms, verses 26 percent of those treated with medication.

The FDA is not legally required to follow the recommendations of its advisory panels, but in most cases, it does.

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