Clever old Medtronic, Inc. has chased down an FDA approval for the use of its its Lead Integrity Alert (LIA) software for use with non-Medtronic leads. This piece of proprietary and exclusive software that resides in Medtronic defibrillators is now approved to report performance issues on St.Jude Medical’s Durata® and Riata® defibrillator leads as well as Boston Scientific’s Endotak® defibrillator leads when connected to a Medtronic device.
LIA was originally approved by the FDA in 2008 for use with Medtronic defibrillators and leads. However, in the U.S., Medtronic’s CareLink® remote monitoring Network has established that approximately 12,000 Medtronic LIA-enabled defibrillators (ICDs and CRT-Ds) are connected to non-Medtronic leads. This includes approximately 5,100 Endotak leads(Boston Scientific); 6,100 Riata/Durata® leads (St.Jude Medical); and nearly 500 leads from other manufacturers, including Biotronik and others.
An analysis recently published in Circulation: Arrhythmia and Electrophysiology suggest that LIA has shown the ability to detect pace/sense lead issues in non-Medtronic leads at a greater rate than standard impedance (four times daily) monitoring alone. Specifically, for Durata® and Riata® leads (St. Jude Medical), pace/sense circuit issues were detected by the LIA software approximately six times more frequently than with impedance monitoring. Likewise, for Endotak® (Boston Scientific) leads, pace/sense circuit issues were detected four times more frequently with LIA software.
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.
“This approval affirms the applicability of Medtronic’s LIA-enabled defibrillators in detecting lead issues in those leads developed by other manufacturers,” said Kenneth A. Ellenbogen, M.D., Kontos Professor of Cardiology at the VCU School of Medicine and Medical College of Virginia Hospital.
“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 and general manager of the tachycardia business at 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.”
Source: Medtronic, Inc.