Five-year results from the remedē System Post Approval Study were presented at late-breaking sessions at two international scientific conferences, Heart Failure Society of America (HFSA) 2020 and CHEST 2020. Marketed by Respicardia, the remedē System was approved to treat moderate to severe central sleep apnea (CSA) in adult patients by the US Food and Drug Administration (FDA) in 2017. The newly released data assesses the safety and efficacy of transvenous phrenic nerve stimulation for CSA.
The remedē System is an implantable device that activates automatically each night to stimulate phrenic nerve in the chest, which sends signals to the diaphragm to help restore a normal breathing pattern. 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. 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.” says Maria Rosa Costanzo, MD, principal investigator for the pivotal trial of the remedē System and medical director at Edward Hospital Center for Advanced Heart Failure and Heart Failure Research at Advocate Heart Institute, in a release. “We also saw substantial and clinically meaningful improvements in the sleep architecture. 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.”
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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 results. The 5-year results include:
- 96% reduction in central apneas
- Overall apnea hypopnea index (AHI) reduced by 22 events/hour of sleep
- Arousals reduced by 14 events/hour of sleep
- Fourteen percentage point (absolute) increase in deep sleep (N2 – REM) and a 19 percentage point decrease in light stage sleep (N1)
- Sustained improvement in daytime sleepiness
- Consistent safety, in line with previously published data.
“Congratulations to all of the coauthors, study investigators, and patients who have contributed to the data collection and publication of this 5-year study,” says Robin Germany, MD, chief medical officer of Respicardia, in a release. “This is an important milestone showing durable, long-term effectiveness and a strong safety profile. We will continue to advance research on central sleep apnea and transvenous phrenic nerve stimulation as we increase access to the therapy for patients in need.”