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Medtronic AT500 Pacer For AT To Compete With St. Jude Integrity

This article was originally published in The Gray Sheet

Executive Summary

Medtronic plans to launch its AT500 pacing system in April to treat bradycardia patients with concomitant atrial tachyarrhythmias (AT). The device received PMA approval March 27

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St. Jude OASES

Dynamic Atrial Overdrive pacing algorithm lowers atrial fibrillation burden - measured as total minutes in AF - up to 72%, according to results of OASES, a randomized, placebo-controlled trial presented at NASPE May 20 in Washington, D.C. DAO is featured in St. Jude Medical's Integrity AFx DR, Identity ADx DR and Integrity Micro DR pacers, and in the recently-approved Epic+ DR ICD. St. Jude's DAO pacers compete with Medtronic's AT500 pacemaker, which was approved earlier this with an AF suppression algorithm (1"The Gray Sheet" March 31, 2003, p. 32)...

St. Jude OASES

Dynamic Atrial Overdrive pacing algorithm lowers atrial fibrillation burden - measured as total minutes in AF - up to 72%, according to results of OASES, a randomized, placebo-controlled trial presented at NASPE May 20 in Washington, D.C. DAO is featured in St. Jude Medical's Integrity AFx DR, Identity ADx DR and Integrity Micro DR pacers, and in the recently-approved Epic+ DR ICD. St. Jude's DAO pacers compete with Medtronic's AT500 pacemaker, which was approved earlier this with an AF suppression algorithm (1"The Gray Sheet" March 31, 2003, p. 32)...

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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