Skip to main content
doctor shaking hands with older adult male

RESULTS

THAT DELIVER CONFIDENCE

remedē® System Pivotal Trial

The remedē System Pivotal Trial was a prospective, multi-center, randomized trial to evaluate the safety and effectiveness of therapy delivered by the remedē System in adult patients with moderate to severe CSA and optimal medical management. After 6 months of data was collected on the treatment and control groups, the former control group began receiving therapy. Results versus baseline were then studied out to five years for the treatment and former control groups.1-2

The remedē System is a proven sleep therapy specifically designed for treating central sleep apnea (CSA) with consistent and sustained long-term safety and effectiveness. It has been shown to reduce the severity of CSA, improve sleep, breathing, and quality of life.1

The results of the study demonstrate that the remedē System is safe and effective, with all primary and secondary endpoints achieved.2 TREATMENT EFFECTIVENESS and SAFETY were sustained through five years.1 No deaths associated with the procedure, the remedē System, or delivered therapy have been reported through five years. 

The results of the remedē System Pivotal Trial demonstrate comprehensive improvements in sleep and quality of life beyond improvements in AHI1-3

Reduction in Sleep Disturbances

  • 96% reduction in Central Apnea Index1
  • 88% of patients experienced a reduction in AHI2,3
  • Significant reduction in oxygen desaturation events1

Improvement in Sleep Quality

  • Significant reduction in arousals1
  • Significant improvement in sleep architecture1

Improvement in Quality of Life

  • 95% of patients reported they would “elect to have the medical procedure again”3
  • 78% of patients reported improved quality of life3
  • Significant reduction in daytime sleepiness1

Reduction in Sleep Disturbances

96% reduction in Central Apnea Index at 1 year
61% reduction in Apnea-Hypopnea Index
88 percent pie chart

88% of patients had a reduction in the number of apnea and hypopnea events per hour of sleep2,3

Clinically significant improvements in oxygen desaturation index (ODI4) and sleep time with oxygen saturation <90%3

Improvement in Sleep Quality

Significant improvement in sleep chart

Improvement in Quality of Life

78 percent pie chart

78% of patients reported quality of life improvement using the Patient Global Assessment3

95 percent pie chart

95% of patients reported they would “elect to have the medical procedure again”3

3-point ESS improvement

Improvement in daytime sleepiness, as evidenced by a 3.0 point improvement in Epworth Sleepiness Scale3

The remedē System Pivotal Trial demonstrates the high implant success rate and safety of the procedure and therapy.1,2

Implant Success

97 percent

97% implant success rate2

Freedom from Serious Adverse Events

90 percent pie chart

90% of patients experienced freedom from serious adverse events associated with implant procedure, the remedē System, or delivered therapy at 12 months. 86% experienced freedom from associated serious adverse events through five years.1

Additional post-hoc analysis on heart failure patient cohort

The following data is intended to address questions raised by clinicians about how patients with heart failure and reduced ejection fraction responded when their moderate to severe CSA was treated with remedē.

We continue to collect and publish clinical evidence.

Read peer-reviewed publications and abstracts on phrenic nerve stimulation for CSA.

Unless otherwise noted, data reported as medians and percent change in observed median.