Newly published results from 24- and 36-month data from the remed? System Pivotal Trial demonstrate long-term safety and sustained improvement in sleep metrics from phrenic nerve stimulation in adult patients with moderate to severe central sleep apnea (CSA). The study is published in Sleep and funded by Respicardia Inc, the remed? System.
“It is imperative that we understand the long-term results of phrenic nerve stimulation since CSA and its underlying disorders are chronic and progressive,” says Henrik Fox, MD, senior cardiologist at Ruhr-Universität Bochum, Bad Oeynhausen, Germany, in a release. “The durability of the clinical results seen in this trial further validates the remed? System as an effective, reliable, long-term treatment option for indicated patients.”
Patients from the remed? System Pivotal Trial were assessed at 24 months (full overnight, in-lab, attended polysomnogram) and 36 months (home sleep study of cardiorespiratory polygraphy) to evaluate sleep metrics and safety. All sleep studies were scored by a central sleep core laboratory.
The results at 24-months include:
- 99% reduction in the median of the central apnea index (CAI) from baseline
- 93% of patients had a reduction in the apnea-hypopnea index (AHI) from baseline
- 59% reduction in the median arousal index from baseline
- Improved rapid eye movement (REM) sleep and the percentage and minutes of sleep with oxygen saturation less than 90%, which is an independent predictor of all-cause mortality in chronic heart failure
- 90% of patients were free from serious adverse events associated with the implant procedure, the remed? System, or delivered therapy through 24 months. No additional related serious adverse events were reported between 24 and 36 months.
The control arm showed similar results once therapy was activated after a pre-specified 6-month randomization period. The improvement in sleep metrics for both groups was sustained and consistent at 36 months.
The latest results build upon prior published data in The Lancet and the American Journal of Cardiology, which demonstrated that the remed? System significantly reduces the severity of CSA and improves sleep, quality of life and patient satisfaction, and the benefits are sustained.
Respicardia Initiates New Clinical Study
Respicardia also announced the initiation and first patient enrollments into a major new clinical study: the remed? System Therapy Study (r?ST Study), a multi-center, prospective, open-label, single-arm study to collect safety and effectiveness data in approximately 500 remed? System patients in the United States and Europe for up to 5 years. To assess effectiveness, the study will evaluate changes in sleep metrics, daytime sleepiness, quality of life and, for patients with heart failure, core-lab determined cardiac remodeling biomarkers as well as functional capacity. The first global enrollments occurred July 9, 2019 at Novant Health Forsyth Medical Center in Winston-Salem, NC, and were implanted by Michael N. Drucker, MD, who says, “We are very excited to be leading the way and enrolling the first two patients into the r?ST Study. Phrenic nerve stimulation has enormous potential to treat central sleep apnea patients who currently have few therapeutic options. The r?ST Study will give us further insight into the impact of the therapy and long-term outcomes.”
“We are dedicated to offering physicians and their patients a clinically proven CSA treatment option with long-term safety and benefits,” says Peter Sommerness, president and CEO of Respicardia. “The 3-year data from the IDE Pivotal Trial combined with the initiation of the r?ST Study further strengthens our clinical foundation and supports our commitment to improving patient outcomes.”