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New Technology Could Help Patients with Defective Medtronic Sprint Fidelis Defibrillator Leads | cialis online

New Technology Could Help Patients with Defective Medtronic Sprint Fidelis Defibrillator Leads

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Medtronic has introduced a software update for its implantable defibrillators that will detect lead fractures, which could help the thousands of people implanted with the recalled Sprint Fidelis defibrillator lead. The Food & Drug Administration (FDA) announced the approval of the update,  called the Lead Integrity Alert, yesterday, and said in a press release that it would be of particular help to patients still implanted with a recalled Sprint Fidelis defibrillator lead wire.

According to the FDA, the new technology issues an audible alert once it detects signals that could indicate that the lead has fractured, and then repeats the alert every four hours until a physician can reset the defibrillator. In addition to an audible alert, the new software 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. The physician can download the Lead Integrity Alert feature onto Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

“This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a press release. “While the software doesn’t fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”

A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear.

Medtronic suspended sales of the Sprint Fidelis Leads last October after receiving reports of 5 fatalities linked to lead fractures. The Sprint Fidelis had been fracturing at a rate of 2.3% over a 30-month period, more than twice that of an older Medtronic lead, called the Sprint Quattro.

By the time Medtronic issued the recall, the lead had green implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide. The FDA says most of the patients with the Sprint Fidelis lead still have the device implanted because of the danger associated with removal, and are being monitored by their health-care providers for potential fracture.

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