Medtronic on Thursday announced U.S. Food and Drug Administration approval of its Lead Integrity Alert (LIA) software for use with non-Medtronic leads.
The software, which has been a standard feature on Medtronic devices since 2008, 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. Those leads must be connected to a Medtronic device.
Medtronic said LIA has shown the ability to detect 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.
For Durata and Riata leads, Medtronic said its software detected circuit issues six times more frequently than impedance monitoring. For Endotak, circuit issues were detected four times more frequently, Medtronic said.
In the U.S., approximately 12,000 Medtronic LIA-enabled defibrillators are connected to non-Medtronic leads, the company said. That includes approximately 5,100 Endotak leads and 6,100 Riata and Durata leads.
Leads are considered the weak link in pacemaker and defibrillator therapy. The thin wires can fracture, disconnect from the heart and short-circuit. St. Jude's Riata lead was removed from the market in late 2010 after it was discovered that the lead's inner wires were coming through its outer insulation. A year later, the FDA recalled the device.
St. Jude Medical has repeatedly said it has seen no similar problems with its Durata leads, pointing to years of data and monitoring of thousands of patients.
