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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 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
SEE THE SLEEP DISTURBANCES DATA

Improvement in Sleep Quality

  • Significant reduction in arousals1
  • Significant improvement in sleep architecture1
SEE THE SLEEP QUALITY DATA

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
SEE THE QUALITY OF LIFE DATA

Reduction in Sleep Disturbances

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

We continue to collect and publish clinical evidence.

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

See publications

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

  1. Costanzo MR, Javaheri S, Ponikowski P, et al. Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes. Nat Sci Sleep. 2021;13:515-526.
  2. Constanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974-82.
  3. Costanzo MR, Ponikowski P, Javaheri S, 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.