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. The remedē System is MR Conditional but conditions apply. Please make sure that your physician knows about the conditions and precautions to ensure safety, which can be found in the remedē System MRI guidelines manual. You should not have the remedē System implanted if you have an infection and you will not be able to have diathermy (special heat therapies) after implantation. 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.