Medtronic (NYSE:MDT) said the FDA granted pre-market approval for its lead integrity alert software for use with defibrillator leads made by arch-rivals St. Jude Medical (NYSE:STJ) and Boston Scientific (NYSE:BSX).
The LIA software, designed to detect problems with the leads, had been approved since 2008 but only for Medtronic products, according to a press release. The new approval allows it to be used to detect performance issues with St. Jude Medical and Boston Scientific defibrillator leads when they’re connected to a Medtronic device, the company said.
Citing an analysis in Circulation: Arrhythmia and Electrophysiology, the Fridley, Minn.-based medical device company said the LIA software detected problems with St. Jude’s Riata and Durata leads 6 times more frequently than with impedance monitoring. Problems with Boston Scientific’s Endotak leads were detected 4 times more frequently than with impedance monitoring, Medtronic said.
“We’ve seen the effectiveness of the LIA software with Medtronic devices and leads these past 4 years, and we know it can have an impact beyond our leads. 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,” tachycardia general manager Dr. Marshall Stanton said in prepared remarks.
There are roughly 12,000 Medtronic defibrillators with the LIA software connected to non-Medtronic leads in the U.S., according to the release, including about 6,100 Riata or Durata leads, 5,100 Endotak leads and some 500 leads made by other medtech firms including Biotronik.