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Remote Monitoring Databases Should Also Track Pacing Leads, Experts Say

This article was originally published in The Gray Sheet

Executive Summary

Cardiac rhythm management device manufacturers say they will register cardiac leads separately in ICD and pacemaker remote monitoring databases to better track post-market lead performance

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Correction on St. Jude Medical’s Riata lead

While concerns about the firm's Riata defibrillator lead causing perforations have been raised in journal articles and FDA adverse event reports, the firm has never issued a physician notification or alert for the device, as was erroneously reported by "The Gray Sheet" (1Oct. 13, 2008, p. 15). At a Heart Rhythm Society meeting in May, St. Jude presented an analysis from four prospective studies showing very low lead-related complication rates. The firm continues to emphasize the safety and reliability of the device

Correction on St. Jude Medical’s Riata lead

While concerns about the firm's Riata defibrillator lead causing perforations have been raised in journal articles and FDA adverse event reports, the firm has never issued a physician notification or alert for the device, as was erroneously reported by "The Gray Sheet" (1Oct. 13, 2008, p. 15). At a Heart Rhythm Society meeting in May, St. Jude presented an analysis from four prospective studies showing very low lead-related complication rates. The firm continues to emphasize the safety and reliability of the device

Experts Call For Better Pre-clinical ICD Lead Testing

The current standard of pre-clinical testing for ICD leads is inadequate, but efforts to improve lead design and safety are underway, according to the new president of the Heart Rhythm Society

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