MINNEAPOLIS and DENVER – May 10, 2013 – Data presented today at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions, show that Medtronic, Inc. (NYSE:MDT) Lead Integrity Alert (LIA) software detected 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). The retrospective analysis, which focused on Endotak® leads (Boston Scientific) and was presented by Dr. Kenneth Ellenbogen, shows that for every one Endotak pace/sense lead issue detected by impedance monitoring, the LIA software detected four cases that impedance monitoring alone missed. LIA is not currently FDA approved for use with non-Medtronic leads.
Data previously presented at the American Heart Association Scientific Sessions in 2012 showed that for every one Riata® pace/sense lead (St. Jude Medical) issue detected by impedance monitoring, the LIA software detected approximately six cases that impedance monitoring alone missed.
Approved by the FDA in 2008 for use with Medtronic defibrillators and leads, LIA is proprietary and exclusive software that resides on Medtronic devices. Medtronic has submitted a PMA-Supplement requesting FDA approval to add LIA performance on non-Medtronic leads to the device labeling.
“We’ve seen the effectiveness of the LIA software with Medtronic devices and leads these past four years, but physicians have been asking about its use with other manufacturers’ leads,” said Marshall Stanton, M.D., vice president and general manager, Implantable Defibrillator Business, Cardiac Rhythm Disease Management at Medtronic. “This analysis underscores our commitment to providing implanting physicians with the latest clinically relevant, advanced decision-making tools to benefit the health and well-being of their patients.”
In the U.S., approximately 17,000 Medtronic LIA-enabled defibrillators (ICDs and CRT-Ds) are connected to non-Medtronic leads, as identified and monitored remotely via the Medtronic CareLink® Network. This includes approximately 7,700 Endotak leads; 8,800 Riata/Durata® leads from St. Jude Medical; and nearly 500 leads from other manufacturers, including Biotronik and others. Non-Medtronic lead issues identified by LIA were adjudicated by an external panel of physicians who had access to device-stored electrograms and the clinical interpretation of the treating physician.
“These findings shed light on the applicability of Medtronic’s LIA-enabled defibrillators in detecting lead issues in those leads developed by other manufacturers,” said Dr. Ellenbogen, Kontos Professor of Cardiology at the Medical College of Virginia.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.
About Medtronic Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
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