Medtronic Fidelis Lead Failure Rate Climbs, But New Software May Help
This article was originally published in The Gray Sheet
Executive Summary
Medtronic hopes new software for monitoring the integrity of implantable cardioverter defibrillator leads will allay physicians' and patients' fears about the high failure rate of the firm's Fidelis leads
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Medtronic Fidelis Fracture Rates Accelerate Over Time, Study Finds
Fracture rates with Medtronic's Sprint Fidelis implantable cardioverter defibrillator leads are increasing over time, according to new research published online Feb. 23 by the journal HeartRhythm
Medtronic Fidelis Fracture Rates Accelerate Over Time, Study Finds
Fracture rates with Medtronic's Sprint Fidelis implantable cardioverter defibrillator leads are increasing over time, according to new research published online Feb. 23 by the journal HeartRhythm
Medtronic Fidelis update
Failure rate for Medtronic's Fidelis ICD lead is 4.8% (+2.1 or -3.6) at 39 months, according to data from the firm's System Longevity Study, and 3.5% (+0.6 or -0.6) according to data from its CareLink remote monitoring network, the company reports Aug. 29. Medtronic recalled the size 7 French lead in October 2007 when the System Longevity Study and CareLink network showed the 30-month failure rate was 2.3%. By contrast, the failure rate for Medtronic's Quattro lead is 0.9% (1"The Gray Sheet" Oct. 22, 2007, p. 3). Separately, on Sept. 4, FDA approved an update to the software Medtronic is using to track Fidelis lead fractures called the Lead Integrity Alert. The feature allows defibrillators to make an audible tone when it detects a possible lead fracture