Medtronic has obtained the US Food and Drug Administration (FDA) approval for its Lead Integrity Alert (LIA) software for use with non-Medtronic leads to detect defibrillator lead issues.
LIA software has been approved by the FDA to report performance issues on St. Jude Medical’s Durata and Riata defibrillator leads, and Boston Scientific’s Endotak defibrillator leads when connected to a Medtronic device.
According to an analysis recently published in Circulation: Arrhythmia and Electrophysiology, the LIA software has demonstrated the capability of detecting pace/sense lead issues in non-Medtronic leads at a greater rate than standard impedance monitoring alone.
For Endotak leads, the LIA software has detected pace/sense circuit issues four times more frequently than with impedance monitoring.
For Durata and Riata leads, the software detected pace/sense circuit issues six times more frequently than with impedance monitoring
LIA was originally approved by the FDA in 2008 for use with Medtronic defibrillators and leads.
In the US, around 12,000 Medtronic LIA-enabled defibrillators (ICDs and CRT-Ds) are connected to non-Medtronic leads that include around 5,100 Endotak leads; 6,100 Riata/Durata leads; and nearly 500 leads from other manufacturers, including Biotronik and others.
LIA identified non-Medtronic lead issues were adjudicated by an external panel of physicians who had access to device-stored electrograms and the clinical interpretation of the treating physician.
Medtronic tachycardia business vice president and general manager Dr Marshall Stanton noted the company has seen the effectiveness of the LIA software with Medtronic devices and leads these past four years, and the company knows it can have an impact beyond its leads.
"LIA detects lead failures better than impedance alone and this approval provides implanting physicians with performance information on this advanced decision-making tool to benefit the health and well-being of their patients," Dr Stanton added.
LIA is included in the SmartShock suite of algorithms that yields the lowest occurrence rate of inappropriate shocks for any defibrillator in the industry, the company claims.