Medtronic ($MDT) picked up FDA approval to use some of its patient-safety software with devices from rivals St. Jude Medical ($STJ) and Boston Scientific ($BSX), possibly giving the world's largest devicemaker a marketing boost in one of its flattening businesses.
The company's Lead Integrity Alert software, installed in Medtronic's implanted defibrillators, is designed to track the performance of wires running to the heart and sense lead issues more often than standard impedance monitoring. The FDA first approved the software for use with Medtronic leads in 2008, and now the agency has stretched its blessing to include St. Jude's Riata and Durata and Boston Scientific's Endotak thanks to some promising study results.
Cardiologists often mix and match leads and ICDs depending on a patient's needs, and Medtronic is counting on the latest approval to establish its line of defibrillators as the industry's go-to, no matter whose wires a physician favors, Medtronic Tachycardia General Manager Marshall Stanton said.
"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," Stanton said in a statement. "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."
In data supporting the approval, LIA detected Riata and Durata issues 6 times more frequently than impedance monitoring and four times more often with Endotak, Medtronic said.
The FDA's nod could help Medtronic better market its sweeping slate of ICDs, whose revenue slipped 3% to $655 million last quarter and has remained largely flat over the past year. Cardiac rhythm disease management is by far Medtronic's largest business, bringing in nearly $5 billion last fiscal year, but pricing pressures and declining demand have hampered the segment's progress of late, and Medtronic is focusing on high-growth spaces like healthcare service technologies and neuromodulation devices to make up ground.
- read the announcement