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Biotronik trial milestones

This article was originally published in The Gray Sheet

Executive Summary

Biotronik enrolls the first patient July 23 in its 1,750-patient REPLACE registry, the first and largest prospective trial focusing on complications associated with replacements and system upgrades of FDA-approved implantable pacemakers and defibrillators. The registry will be conducted in 75 to 100 U.S. centers and will include all manufacturers' models. Also on July 23, Biotronik completed enrollment in its 1,000-patient TRUST study. The randomized, prospective trial is evaluating if patients with Lumos and Lumax VT-T/DR-T defibrillators followed by Biotronik's Home Monitoring and IEGM Online remote monitoring technology have outcomes at least equivalent to those receiving standard in-person follow up...

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