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St. Jude

This article was originally published in The Gray Sheet

Executive Summary

Patients enrolled in the U.S. Atrial Dynamic Overdrive Pacing Trial (ADOPT-A) are being implanted with the Integrity AFx (model 5346) AutoCapture pacing system with Dynamic Atrial Overdrive (DAO) algorithm for suppression of atrial fibrillation under an FDA investigational device exemption. The trial is designed to test whether DAO, an investigational feature, can suppress episodes of paroxysmal atrial fibrillation and includes patients with bradycardia and AF. The top-line Integrity was launched in dual-chamber (model 5342) and single-chamber (model 5142) options May 10 at a slight premium to St. Jude's Affinity pacer line. Integrity implants outside of ADOPT-A are not enabled to perform DAO, but have the capability, the company notes

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