Medtronic:FDA Oks Lead Integrity Alert Software For Use With Non-Medtronic Leads

(RTTNews) - Medtronic Inc. (MDT) announced FDA approval of its Lead Integrity Alert or 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.