November 7, 2013 — Medtronic Inc. announced U.S. Food and Drug Administration (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 displayed the ability to detect pace/sense lead issues in non-Medtronic leads at a greater rate than standard impedance monitoring alone, according to an analysis recently published in Circulation: Arrhythmia and Electrophysiology. For Durata and Riata leads (St. Jude Medical), LIA software detected pace/sense circuit issues approximately six times more frequently than with impedance monitoring. The software detected pace/sense circuit issues more frequently for Endotak (Boston Scientific) leads as well.
"This approval affirms the applicability of Medtronic's LIA-enabled defibrillators in detecting lead issues in those leads developed by other manufacturers," said Kenneth Ellenbogen, M.D., Kontos Professor of Cardiology, Virginia Commonwealth University (VCU) School of Medicine and Medical College, Virginia Hospital.
In the United States, approximately 12,000 Medtronic LIA-enabled defibrillators (implantable cardioverter defibrillators (ICDs) and cardiac resynchronizationtherapy devices (CRT-Ds)) are connected to non-Medtronic leads, as identified and monitored remotely via the Medtronic CareLink Network. This includes approximately 5,100 Endotak leads, 6,100 Riata/Durata leads from St. Jude Medical and nearly 500 leads from other manufacturers, including Biotronik. An external panel of physicians who had access to device-stored electrograms and the clinical interpretation of the treating physician adjudicated non-Medtronic lead issues identified by LIA.
"We've seen the effectiveness of the LIA software with Medtronic devices and leads these past four years, and we know it can have an impact beyond our leads," said Marshall Stanton, M.D., vice president, Medtronic. "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."
LIA is included in the SmartShock suite of algorithms that yields the lowest occurrence rate of inappropriate shocks for any defibrillator in the industry. [i] [ii]
For more information: www.medtronic.com
[i] Schloss EJ, et al. PainFree SST Trial Primary Results: Low Shock Rates in Patients with Dual and Triple Chamber ICDs Using Novel Detection Algorithms. Heart Rhythm. 2013;10(50):S64.
[ii] Schloss E, et al. PainFree SmartShock technology: trial primary results: inappropriate shock rates in patients with single chamber ICD's using a novel suite of detection algorithms. EHRA Europace 2013 Late Breaking Trial session 1.