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Medtronic Reports FDA Approval for Proprietary Software for Use with Non-Medtronic Leads to Detect Defibrillator Lead Issues

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Medtronic, Inc. (NYSE: MDT) today announced FDA approval of its Lead Integrity Alert (LIA) software for use with non-Medtronic leads. Proprietary and exclusive software that resides in Medtronic defibrillators, LIA is now approved to report performance issues on Durata^® and Riata^® defibrillator leads (St. Jude Medical) and Endotak^® (Boston Scientific) defibrillator leads when connected to a Medtronic device.

Originally approved by the FDA in 2008 for use with Medtronic defibrillators and leads, LIA has shown the ability to detect pace/sense lead issues in non-Medtronic leads at a greater rate than standard impedance monitoring alone (impedance monitoring measures the electrical continuity of a lead four times per day), according to an analysis recently published in Circulation: Arrhythmia and Electrophysiology.  For Durata^® and Riata^® leads (St. Jude Medical), pace/sense circuit issues were detected by the LIA software approximately six times more frequently than with impedance monitoring.  Likewise, for Endotak^® (Boston Scientific) leads, pace/sense circuit issues were detected four times more frequently with LIA software. 

Posted-In: News FDA


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