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CHICAGO, Sept 4 (Reuters) - The U.S. Food and Drug Administration said on Thursday it approved a software update from Medtronic Inc (MDT.N) that will help detect fractures of the company’s Sprint Fidelis heart defibrillator lead, the subject of an October 2007 recall.
The lead, or the wire that delivers electrical pulses from the implanted defibrillator to the heart, was recalled because it was prone to fracture in a small number of patients, potentially causing the lead to deliver unnecessary shocks or not operate at all.
The software, called the Lead Integrity Alert, will alert both patients and physicians of a potential lead fracture, enabling early intervention and lowering the risk of serious complications, the FDA said.
The system issues an audible alert once it detects signals that could indicate that the lead has fractured and repeats the alert until the physician resets the defibrillator. It also modifies the device settings so the defibrillator has more time to consider whether a lead fracture or an abnormal heart rhythm has occurred, a change intended to reduce the number of inappropriate defibrillator shocks.
Most of the patients with the Sprint Fidelis lead still have the device implanted in the wake of the recall because of the surgical risk associated with removal. Those patients are being monitored by their health-care providers for potential fracture, the FDA said.
“This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” Dr. Daniel Schultz, director of the Center for Devices and Radiological Health, FDA, said in a prepared statement. “While the software doesn’t fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”
Medtronic shares were off 54 cents at $54.60 in early New York Stock Exchange trade. (Reporting by Debra Sherman, editing by Gerald E. McCormick, Dave Zimmerman)