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.
Ten out of 10 Circulatory System Devices advisory panel committee members voted that there is assurance of effectiveness of the Ablation Frontiers Cardiac Ablation System, but nine out of 10 deemed the ablation system as unsafe.
“To the sponsor, I hope what you’ve heard today is not a ‘no,’ but a ‘not yet,’” said Dr. Clyde Yancy, chairman of the watchdog agency’s circulatory devices panel, according to Reuters. “There is a feeling that this system is effective, but there are concerns that the safety bars have not been met.”
I, for one, am grateful that they simply didn’t push this system through and are encouraging further research and evaluation before an approval can be given!
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.
The device, which Medtronic acquired when it bought Ablation Frontiers in 2009, uses radiofrequency energy to destroy the heart muscle cells that cause persistent atrial fibrillation – an irregular heartbeat that lasts between seven days and four years. Although it proved to be effective in treating AF in patients who didn’t respond to standard drug therapy, the device failed to meet a clinical trials safety endpoint, according to the FDA report.
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.
“FDA is concerned about the overall safety profile of the system,” according to the report. According to the executive summary presented by Medtronic, there was a 90% or greater reduction in AF or atrial flutter burden at 6 months in more than 55% of patients treated with the cardiac ablation system. Clinically relevant improvements in quality of life measures and reduction in symptom severity were also noted.
However, results also showed a peri-procedural stroke rate of 2.8% among 176 patients in the study, as well as ischemic stroke in five patients within one month of the study procedure. The committee members found these results to be of concern, and said the ablation system was not yet ready for approval.
Be it known however, though that the FDA is not legally required to follow the recommendations of its advisory panels, but in most cases, it does.
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