Recently, the U.S. Food and Drug Administration (FDA) agency instructed medical devices major, St. Jude Medical, Inc.to conduct a study to examine insulation failure in Riata defibrillator leads, a thin wire used to connect cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter defibrillator (ICD) to the heart to monitor abnormal heart rhythm.
The agency has recommended that X-rays or other imaging alternatives should be conducted in patients who have been implanted with the heart device to increase clinical know-how. The FDA also recommended St. Jude to carry out post-market surveillance studies to accumulate information regarding the risks associated with the Riata leads for 3 years.
