Medtronic’s lead alert system gets FDA approval for use with non-Medtronic devices

7 November 2013 (Last Updated November 7th, 2013 18:30)

Medtronic has secured the US Food and Drug Administration (FDA) approval for its Lead Integrity Alert (LIA) software, designed for use with Durata and Riata (St Jude Medical) and Endotak (Boston Scientific) defibrillator leads.

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Medtronic has secured the US Food and Drug Administration (FDA) approval for its Lead Integrity Alert (LIA) software, designed for use with Durata and Riata (St Jude Medical) and Endotak (Boston Scientific) defibrillator leads.

The LIA software is designed to detect problems with the leads had been approved since 2008 but only for Medtronic products.

According to an analysis recently published in Circulation: Arrhythmia and Electrophysiology, LIA has shown the ability to detect 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 a day.

The new approval allows the software to be used to detect performance issues with St Jude Medical and Boston Scientific defibrillator leads when connected to a Medtronic device.

LIA software detected the pace/sense circuit issues of Durata and Riata leads (St Jude Medical), approximately six times more frequently than with impedance monitoring.

Similarly, for Endotak (Boston Scientific) leads, pace/sense circuit issues were detected four times more frequently with LIA software.

VCU School of Medicine and Medical College of Virginia Hospital Kontos professor of cardiology Dr Kenneth A Ellenbogen said: "This approval affirms the applicability of Medtronic's LIA-enabled defibrillators in detecting lead issues in those leads developed by other manufacturers."

"This approval affirms the applicability of Medtronic's LIA-enabled defibrillators in detecting lead issues in those leads developed by other manufacturers."

As identified and monitored remotely via the Medtronic CareLink Network, there are approximately 12,000 Medtronic LIA-enabled defibrillators (ICDs and CRT-Ds) connected to non-Medtronic leads in the US.

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 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.

Medtronic tachycardia business vice-president and general manager Dr Marshall Stanton said the company has seen the effectiveness of the LIA software with Medtronic devices and leads these past four years.

"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 said.

LIA is included in the SmartShock suite of algorithms that yields the lowest occurrence rate of inappropriate shocks for any defibrillator in the industry.


Image: Medtronic's global headquarters in Minneapolis, US. Photo: courtesy of Medtronic.