11.07.13
Minneapolis, Minn.-based Medtronic Inc. has earned expanded approval from the U.S. Food and Drug Administration (FDA) for its Lead Integrity Alert (LIA) software for use with non-Medtronic leads. LIA is a proprietary and exclusive software that resides in Medtronic defibrillators, but is now approved to report performance issues on Durata and Riata defibrillator leads (made by St. Jude Medical) and Endotak defibrillator leads (made by Boston Scientific) when connected to a Medtronic device.
Originally approved by the FDA in 2008 for use with Medtronic defibrillators and leads, LIA has reportedly shown the ability to detect pace and 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), according to an analysis recently published in Circulation: Arrhythmia and Electrophysiology. For Durata and Riata leads, pace and sense circuit issues were detected by the LIA software approximately six times more frequently than with impedance monitoring. Likewise, for Endotak leads, pace and sense circuit issues were detected four times more frequently with LIA software.
“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 Virginia Commonwealth University School of Medicine and Medical College of Virginia Hospital.
In the United States approximately 12,000 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 5,100 Endotak leads; 6,100 Riata or Durata leads; and nearly 500 leads from other manufacturers, including Biotronik. 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.
“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.”
Originally approved by the FDA in 2008 for use with Medtronic defibrillators and leads, LIA has reportedly shown the ability to detect pace and 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), according to an analysis recently published in Circulation: Arrhythmia and Electrophysiology. For Durata and Riata leads, pace and sense circuit issues were detected by the LIA software approximately six times more frequently than with impedance monitoring. Likewise, for Endotak leads, pace and sense circuit issues were detected four times more frequently with LIA software.
“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 Virginia Commonwealth University School of Medicine and Medical College of Virginia Hospital.
In the United States approximately 12,000 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 5,100 Endotak leads; 6,100 Riata or Durata leads; and nearly 500 leads from other manufacturers, including Biotronik. 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.
“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.”