that Deliver Confidence
remedē® SYSTEM PIVOTAL TRIAL
The remedē System Pivotal Trial was a prospective, multi-center, randomized (1:1) controlled trial that enrolled adult patients with moderate to severe CSA based on polysomnographs (in-lab sleep study) scored by a blinded core laboratory. The results of the Pivotal Trial demonstrate the remedē System therapy was safe and effective with all primary and hierarchically tested secondary endpoints met. Treatment effectiveness and quality of life improvements were sustained at 12 months.1,2
At 6 months, 48% of the control group had a positive change in apnea events per hour.
7 Treatment patients missing PSG data counted as failures for reasons related to implant, system or delivered therapy.
remedē® System therapy demonstrated:
81% reduction in the mean of the central apnea index from baseline to 6 months (p<0.0001). The control group had an 11% reduction in the mean of the central apnea index from baseline to 6 months.
44% reduction in the mean of the oxygen desaturation index, demonstrating a significant improvement in oxygenation. This benefit may be associated with a decrease in ischemia, inflammation, and sympathetic drive. The control group had a 10% increase in the oxygen desaturation index.
44% reduction in the mean of the arousal index, which results in decreased norepinephrine release and sympathetic drive (p<0.0001). The control group had a 12% reduction in the mean of the arousal index.
17% improvement in the mean of percent of sleep in REM. The control group had a 5% reduction in REM sleep from baseline to 6 months.
The remedē System Pivotal Trial was the first randomized, controlled trial in CSA patients to demonstrate an improvement in the mean arousal index and REM sleep.
91% of patients experienced freedom from serious adverse events associated with implant procedure, the remedē System, or delivered therapy at 12 months
95% of patients reported they would “elect to have the medical procedure again” 2
Quality of Life1
Patient Global Assessment
- 79% of patients reported an improvement in quality of life
- 13% of the control group patients (untreated patients) reported an improvement in quality of life
Per Protocal Population
* One patient did not complete the PGA assessment at 6 months.
Epworth Sleepiness Scale
- Patients treated with the remedē® System demonstrated clinically significant improvement in daytime sleepiness
Per Protocal Population
At 12 months, sustained benefits were realized by most patients from the remedē® System:
Results were reproduced when the remedē® System therapy was activated in the control group:
- 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;121:1400-8.