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Transvenous phrenic nerve stimulation (The remedA? System) shows sustained safety and efficacy through 5 years

Trial results showed consistent improvement in sleep disordered breathing, arousals, sleep architecture, and daytime sleepiness through 5 years.A MINNETONKA, Minnesota, Oct. 21, 2020 /PRNewswire/ --ARespicardia has announced 5-year results from the remedA? System Post Approval Study, assessing the safety and efficacy of transvenous phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea (CSA).A The data was presented at late-breaking sessions at two international scientific conferences, Heart Failure Society of America (HFSA) 2020 and CHEST 2020.A The remedA? System was approved to treat moderate to severe CSA in adult patients by the U.S. Food and Drug Administration (FDA) in 2017.1 The remedA? System is an implantable device that activates automatically each night to stimulate a nerve in the chest (phrenic nerve) that sends signals to the breathing muscles (diaphragm) to help restore a normal breathing pattern.2 The Post Approval Study followed patients from the pivotal trial through 5 years post implant."Since the initial trials, transvenous phrenic nerve stimulation has proven to be effective and safe in treating moderate to severe central sleep apnea.A Demonstrating sustained benefit through five years is very significant for patients with this disease. The sustained benefit of the therapy is critically important for heart failure patients, whose disease is chronic and progressive." said Dr. Maria Rosa Costanzo, Principal Investigator for the Pivotal Trial of the remedA? System and Medical Director at Edward Hospital Center for Advanced Heart Failure and Heart Failure Research at Advocate Heart Institute. "We also saw substantial and clinically meaningful improvements in the sleep architecture.A The shift to more deep stage sleep seen in this study may partially explain the positive impact this therapy has shown on arousal reduction and overall quality of life improvement. It is important that clinicians who see patients with central sleep apnea consider this therapy."Highlights from the 5-year data show sustained improvements from baseline that were highly consistent with the previously published 6-, 12-, 24-, and 36-month results3.A The 5-year results include4,5:
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