Medtronic Wins FDA Approval for Software that Evaluates Third-Party Leads

Medtronic (Minneapolis, MN) announced that it received FDA approval for its Lead Integrity Alert (LIA) software system. LIA is designed for use with third-party leads. As of now, the LIA software package can report issues associated with Endotak (Boston Scientific) and Durata / Riata (St. Jude Medical) defibrillator leads when they are connected to a device manufactured by Medtronic.LIA first received approval from FDA regulators for use with leads and defibrillators manufactured by Medtronic. Compared to standard impedance monitoring, LIA can detect sense/pace lead issues in third-party leads with better accuracy.Many cardiologists use a combination of different ICDs and leads for a patient, based on his or her unique needs. With this FDA approval in hand, Medtronic hopes to position itself as the go-to company for U.S. cardiologists, regardless of wire branding."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," stated Marshall Stanton, M.D., a vice president 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."