Medtronic nets U.S., EU clearance for defibrillator alert software

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Medtronic has received both FDA and CE Mark approval for its Lead Integrity Alert (LIA) software, designed to provide patients with certain Medtronic defibrillators and defibrillator leads with more advance notice–via an audible sound–of a potential lead fracture that could result in an unnecessary shock.

The Minneapolis-based company said its LIA was developed as a software upgrade for nearly all (98 percent) of the Medtronic implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators implanted in the U.S., and into 93 percent implanted worldwide. Pending further regulatory approvals, Medtronic said that LIA will be included in all future Medtronic implantable defibrillators.