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AF Suppression Algorithm Approval Yields Turn-On For St. Jude Pacer Line

This article was originally published in The Gray Sheet

Executive Summary

St. Jude Medical is confident it will earn a PMA supplement by year-end to activate its Dynamic Atrial Overdrive (DAO) atrial fibrillation suppression algorithm in patients already implanted with the Integrity AFx DR or Integrity Micro AutoCapture cardiac pacers.

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Bradycardia Patients Pose Challenge To Atrial Fibrillation Implants

Ventricular pacing undermines assessments of atrial pacing's ability to reduce AF burden in bradycardia patients, speakers contended during a staged debate at the Boston Atrial Fibrillation Symposium Jan. 16

Bradycardia Patients Pose Challenge To Atrial Fibrillation Implants

Ventricular pacing undermines assessments of atrial pacing's ability to reduce AF burden in bradycardia patients, speakers contended during a staged debate at the Boston Atrial Fibrillation Symposium Jan. 16

St. Jude's Integrity Micro DR

PMA supplement approval is received for a revised version of the firm's 3500/3510 programmer software to activate the dynamic atrial overdrive feature in its Integrity Micro DR Model 5336 pacemaker, intended to reduce incidence of atrial fibrillation in patients paced to treat bradycardia. The feature can now be activated in new Integrity Micro DRs or previously implanted devices. The new software can also be used to activate DAO in the Integrity AFx DR Model 5342. On July 12, the company began shipping Integrity AFx DR devices with the DAO already activated, following premarket approval of the algorithm's inclusion in new pacers, announced July 11. The Integrity Micro DR was approved in December 2000 but required the PMA supplement to activate the DAO feature (1"The Gray Sheet" July 16, 2001, p. 12)

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