Results

that Deliver Confidence

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 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 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

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 three 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 36 months.1

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
  • 99% reduction in Central Apnea Index1
  • 67% reduction in Apnea-Hypopnea Index1
  • Significant reduction in oxygen desaturation events
SEE THE DATA
IMPROVEMENT IN SLEEP QUALITY
  • 57% reduction in arousals1
  • Significant improvement in sleep architecture
SEE THE DATA
IMPROVEMENT IN QUALITY OF LIFE
  • 94% of patients reported they would "elect to have the medical procedure again"3
  • 82% of patients reported improved quality of life3
  • Significant reduction in daytime sleepiness
SEE THE DATA

REDUCTION IN SLEEP DISTURBANCES

graph 1 - Central Apnea Index
graph 2 - Apnea-Hypopnea Index
93

93% of patients had a reduction in the number of apnea and hypopnea events per hour of sleep1

02-icon

Patients experienced clinically significant improvements in oxygen desaturation index (ODI4) and sleep time with oxygen saturation < 90%1

IMPROVEMENT IN SLEEP QUALITY

graph 3 - Arousal Index3

graph 4 - Significant reduction

hidden anchor for offset

IMPROVEMENT IN QUALITY OF LIFE

82%

82% of patients reported quality of life improvement using the Patient Global Assessment3

94%

94% of patients reported they would "elect to have the medical procedure again"3

Epworth Sleepiness Scale

Improvement in daytime sleepiness, as measured by a 5.0 point improvement in Epworth Sleepiness Scale3

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

97%

97% implant success rate2

90%

90% of patients experienced freedom from serious adverse events associated with implant procedure, the remedē System, or delivered therapy at 24 months1

VIEW SERIOUS ADVERSE EVENTS

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.

Review the data

Respicardia continues to collect and publish clinical evidence.

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

SEE Publications
  1. Fox, H., Oldenburg, O., Javaheri, S., et al. SLEEP, zsz158, https://doi.org/10.1093/sleep/zsz158.
  2. Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974–82.
  3. Costanzo M, et al. Sustained Twelve Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea. Am J Cardiol 2018;121:1400-8.
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For Clinicians

IMPORTANT SAFETY INFORMATION

Indications for Use
The remedē® System is an implantable phrenic nerve stimulator indicated for the treatment of moderate to severe central sleep apnea (CSA) in adult patients.

Contraindications
The remedē System is contraindicated for the following:

Warnings

Precautions
It is recommended that testing for oversensing of remedē stimulation therapy by the concomitant cardiac device occur at the time of implant and prior to initiating remedē System therapy in patients with a concomitantly implanted cardiac device. Use remedē System therapy with caution in pacemaker-dependent patients without a physiologic escape rhythm. Device interaction may lead to over or undersensing resulting in a loss of pacing. The safety and effectiveness of the remedē System during pregnancy has not been established.

See the Device Manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

Adverse Effects
Possible adverse events which may be associated with the use implantation and use of the remedē System include, but are not limited to, the following: adverse contrast dye reaction such as allergic reaction, pulmonary edema, or worsening renal function, adverse reaction to radiation exposure, thromboembolism, air embolism, bleeding, cardiac perforation including tamponade, hematoma, seroma, local bruising or swelling, hypotension, local wound healing issues at device implant site including wound dehiscence, pocket erosion, extrusion, movement of implanted device, keloid formation, pneumothorax, hemothorax, vascular damage, e.g., venous dissection, perforation, adverse biocompatibility reaction to the implanted system, infection, lead breakage, lead dislodgement, lead not connected or secured appropriately in device header, implantable device malfunction, requirement for more energy to stimulate the nerve or ineffective stimulation, venous occlusion, crosstalk with another implanted device, disrupted sleep, muscle fatigue or discomfort in diaphragm, chest or abdomen from appropriate stimulation, nerve dysfunction, perturbation of blood gases causing hypoxia, hypercapnea and/or hypocapnea, inappropriate sensations, worsening heart failure, respiratory status or overall health, anxiety, arrhythmia, including ventricular fibrillation, death, depression, hypotension, pain, skin irritation or local allergic reaction, thrombus or embolism, potentially leading to pulmonary embolism or stroke.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.