Medtronic has been given regulatory approvals by U.S. Food and Drug Administration as well as by European regulators (CE Mark) to market the company’s new Lead Integrity Alert™ (LIA) software. This is a software upgrade that will go in “nearly all (98 percent) of the Medtronic implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) implanted in the United States, and into 93 percent implanted worldwide. Pending further regulatory approvals, LIA will be included in all future Medtronic implantable defibrillators,” says Medtronic.
From the press release:
LIA was also developed to enhance patient safety and address patient wellbeing. We believe it will become a standard of care tool to aid in shock reduction. Data shows that with LIA, approximately 76 percent of the patients with Sprint Fidelis leads are expected to receive three or more days advance warning of a potential lead fracture which could result in an unnecessary shock, compared to 49 percent who could receive two or more days advance notice without LIA. This improvement is based on the following LIA features:
Improved sensing capabilities to help detect possible lead fractures earlier on; Increased time between detection of a potential lead fracture and potential delivery of a shock Increased number of times the audible alert sounds each day so that patients are more likely to hear the alert
Upon hearing the alert, patients should contact their physician.
LIA was developed as a software upgrade for nearly all (98 percent) of the Medtronic implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) implanted in the United States, and into 93 percent implanted worldwide.