Research In Brief
This article was originally published in The Gray Sheet
Medtronic lead integrity alert: An algorithm to detect transient pace-sense conductor fractures in Medtronic's Sprint Fidelis implantable cardioverter defibrillator "appears to forewarn most patients ... before inappropriate shocks are delivered," according to an article in the August issue of HeartRhythm. The study, which included all patients at the Minneapolis Heart Institute implanted with Sprint Fidelis leads and Medtronic ICD pulse generators, found that 52 of 461 leads failed between October 2004 and January 2010. Inappropriate shocks were the first sign of lead failure in 69% of the 26 patients whose devices did not have the lead integrity alert capability, versus 17% of the 23 patients who did. Medtronic added the feature, which allows defibrillators to make an audible tone when they detect a potential fracture, in 2008 (1"The Gray Sheet" Sept. 8, 2008). But 32% of patients whose audible alerts were triggered did not immediately hear the tone, the study found
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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
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