IMPROVE

Your Quality of Life

The remedē® System is a breakthrough implantable system that safely and effectively treats moderate to severe central sleep apnea (CSA) in adult patients.3 CSA is a serious breathing disorder that disrupts the normal breathing pattern during sleep and has been shown to negatively impact quality of life and heart health.1

Improve sleep

How it Works

The remedē System is an implantable system that stimulates a nerve in the chest (phrenic nerve) to send signals to the large muscle that controls breathing (the diaphragm). These signals stimulate breathing in the same way that the brain signals breathing.

The remedē System is placed during a minimally invasive outpatient procedure by a cardiologist. The system is a battery powered device placed under the skin in the upper chest area with two small thin wires (leads), one to deliver the therapy (stimulation lead) and one to sense breathing (sensing lead).

The remedē System works to continuously and automatically monitor and stabilize the breathing pattern, restoring sleep throughout the night.

Clinically Proven

In a clinical study, the remedē System has been shown to significantly reduce the effects of CSA:

91% of patients had a
reduction in the number of
sleep apnea events per hour2

82% of patients had an
improvement in quality
of life2

95% of patients would
get remedē® again2

At 6 months, 48% of the control group had a positive change in apnea events per hour and 13% of the control group had an improvement in quality of life.

Commonly Asked Questions

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  1. Costanzo MR, Khayat R, Ponikowski P, et al. State-of-the-art review: Mechanisms and clinical consequences of untreated central sleep apnea in heart failure. J Am Coll Cardiol 2015;65:72-84.
  2. Costanzo M, et al. Sustained Twelve Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea. Am J Cardiol 2018;121:1400-8.
  3. Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974–82.
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For Patients

IMPORTANT SAFETY INFORMATION

The remedē® System is indicated for moderate to severe Central Sleep Apnea in adult patients.

Your doctor will need to evaluate your condition to determine if the remedē system is right for you. You will not be able to have an MRI or diathermy (special heat therapies) if you have the remedē system implanted. The remedē system may be used if you have another stimulation device such as a heart pacemaker or defibrillator; special testing will be needed to ensure the devices are not interacting.

As with any surgically implanted device, there are risks related to the surgical procedure itself which may include, but are not limited to, pain, swelling, and infection.

Once the therapy is turned on, some patients may experience discomfort from stimulation and/or from the presence of the device. The majority of these events are resolved either on their own or by adjusting the therapy settings. The remedē system may not work for everyone. There are additional risks associated with removing your system. If you and your doctor decide to remove the system, another surgery will be required.

Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the remedē system. Rx only. For further information, please call +1-952-540-4470 or email info@respicardia.com.