Medtronic Phased RF Ablation System Raises Safety Concerns, FDA Reviewers Say

Nearly 20 percent of the patients who received an experimental catheter being developed by Medtronic Inc. suffered serious side effects, according to the U.S. Food & Drug Administration (FDA). Medtronic is seeking approval for the catheter as a treatment for atrial fibrillation.

According to a report from the AP, the device, known as the Phased RF Ablation System uses a form of electrical energy to destroy diseased heart tissue that causes the irregular pumping. 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 a report from Reuters, 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.

In a clinical trial, Medtronic studied 210 patients with atrial fibrillation who were randomly selected to receive either treatment with the catheter, or traditional drug therapy. All were monitored for six months. According to the AP, 56 percent with the catheter saw improvement of their symptoms, verses 26 percent of those treated with medications. But FDA regulators have noted that 21 percent experienced a serious side effect, including stroke, heart failure and pneumonia.

“FDA is concerned about the overall safety profile of the system,” the agency states in its review. The review makes particular note of five patients who suffered a stroke just a month after treatment with the catheter, the AP said.

A panel of outside experts will consider the Medtronic catheter at a meeting on Thursday, but the FDA will make a final decision. One analyst told Reuters he thought there was a 50/50 change the agency will approve the device.

Atrial fibrillation, which affects more than 2 million Americans, is the most prevalent heart rhythm disorder, Reuters said.

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