Medtronic's catheter system, which treats a form of atrial fibrillation by blocking abnormal electrical impulses, did not pass safety tests, said a Bloomberg Businessweek report.
One of the FDA's concerns about the device is the high peri-procedural stroke rate observed during the trial. While the device was effective in 56 percent of the 138 patients receiving the treatment, four of them suffered strokes within seven days. An FDA advisory panel is scheduled to tomorrow to discuss the device.
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One of the FDA's concerns about the device is the high peri-procedural stroke rate observed during the trial. While the device was effective in 56 percent of the 138 patients receiving the treatment, four of them suffered strokes within seven days. An FDA advisory panel is scheduled to tomorrow to discuss the device.
Related Articles about FDA Device Approval:
Is There a Middle Ground for Medical Device Approval?
Cook Medical’s GI Stent Approved by the FDA
GE's New MRI Machine Gets FDA Approval