that Deliver Confidence


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.

Modified intention-to-treat
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.



97% implant
success rate


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

Sustained Benefits2

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:

Committed to gathering and publishing clinical evidence.

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

  1. Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974–82.
  2. 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 remedē®?

For Clinicians


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.

The remedē System is contraindicated for the following:


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.