Medtronic Catheter Side Effects Are Cause For Concern: US

Law360, New York (October 26, 2011, 9:02 PM EDT) -- The U.S. Food and Drug Administration raised safety concerns Tuesday involving the clinical trial of a Medtronic Inc. catheter system designed to treat irregular heartbeats, noting that the number of patients who experienced serious side effects had exceeded the expected maximum.

In a memorandum prepared for a Thursday meeting of the agency's Circulatory System Devices Panel, the FDA expressed concerns about the risk-benefit profile and approvability of the Medtronic Cardiac Ablation System, intended to treat long-standing, persistent atrial fibrillation.

Atrial fibrillation, the most common type of...
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