Respicardia, Inc., today announced the publication of the 24- and 36-month data from the remedē® System Pivotal Trial in the peer-reviewed journal SLEEP. The results demonstrate long-term safety and sustained improvement in sleep metrics from phrenic nerve stimulation in adult patients with moderate to severe CSA through 36 months of remedē System therapy.1
“It is imperative that we understand the long-term results of phrenic nerve stimulation since CSA and its underlying disorders are chronic and progressive,” said Henrik Fox, MD, Senior Cardiologist at Ruhr-Universität Bochum, Bad Oeynhausen, Germany. “The durability of the clinical results seen in this trial further validates the remedē System as an effective, reliable, long-term treatment option for indicated patients.”
Patients from the remedē 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 failure2
- 90% of patients were free from serious adverse events associated with the implant procedure, the remedē 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 remedē System significantly reduces the severity of CSA and improves sleep, quality of life and patient satisfaction,3 and the benefits are sustained.4
Along with the publication of this 3-year data, Respicardia also announced the initiation and first patient enrollments into a major new clinical study: the remedē System Therapy Study (rēST Study), a multi-center, prospective, open-label, single-arm study to collect safety and effectiveness data in approximately 500 remedē 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, North Carolina and were implanted by Dr. Michael N. Drucker who commented, “We are very excited to be leading the way and enrolling the first two patients into the rēST Study. Phrenic Nerve Stimulation has enormous potential to treat central sleep apnea patients who currently have few therapeutic options. The rēST 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,” said Peter Sommerness, President and CEO of Respicardia. “The 3-year data from the IDE Pivotal Trial combined with the initiation of the rēST Study further strengthens our clinical foundation and supports our commitment to improving patient outcomes.”
- Fox H, et al. remedē® System Pivotal Trial Study Group, Long-term Efficacy and Safety of Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea Outcomes of Phrenic Nerve Stimulation for Central Sleep Apnea, Sleep. doi.org/10.1093/sleep/zsz158.
- Oldenburg O, Wellmann B, Buchholz A, Bitter T, Fox H, Thiem U, et al. Nocturnal hypoxaemia is associated with increased mortality in stable heart failure patients. Eur Heart J. 2016;37(21):1695-703.
- Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974–82.
- Costanzo M, et al. Sustained Twelve Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea. Am J Cardiol. 2018. pii: S0002-9149(18)30258-3. doi: 10.1016/j.amjcard.2018.02.022.
- CMS-1694-F. FY2019 IPPS Final Rule. Vol. 83, No. 160 Pg. 41320.
- CMS-1695-FC. CY2019 OPPS Final Rule. Vol. 83, No. 225 Pg. 58939.