The U.S. Food and Drug Administration on Friday approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea (CSA). The Remed? System is an implantable device that stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing.
“This implantable device offers patients another treatment option for central sleep apnea,” says Tina Kiang, PhD, acting director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices in the FDA’s Center for Devices and Radiological Health, in a release. “Patients should speak with their healthcare providers about the benefits and risks of this new treatment compared to other available treatments.”
CSA occurs when the brain fails to send signals to the diaphragm to breathe, causing an individual to stop breathing during sleep for a period of 10 seconds or more before restarting again. According to the National Institute of Health’s National Center on Sleep Disorders Research, CSA can lead to poor sleep quality and may result in serious health issues, including an increased risk for high blood pressure, heart attack, heart failure, stroke, obesity, and diabetes. Common treatment options for moderate to severe sleep apnea include medication, positive airway pressure devices (for example, CPAP), or surgery.
The Remed? System is comprised of a battery pack surgically placed under the skin in the upper chest area and small, thin wires that are inserted into the blood vessels in the chest near the nerve (phrenic) that stimulates breathing. The system monitors the patient’s respiratory signals during sleep and stimulates the nerve to move the diaphragm and restore normal breathing.
The FDA evaluated data from 141 patients to assess the effectiveness of the Remed? System in reducing apnea hypopnea index (AHI), a measure of the frequency and severity of apnea episodes. After 6 months, AHI was reduced by 50% or more in 51% of patients with an active Remed? System implanted. AHI was reduced by 11% in patients without an active Remed? System implanted.
The most common adverse events reported included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. The Remed? System should not be used by patients with an active infection or by patients who are known to require magnetic resonance imaging (MRI). This device is not intended for use in patients with obstructive sleep apnea, a condition in which the patient attempts to breathe, but the upper airway is partially or completely blocked.
The FDA granted approval of Remed? System to Respicardia Inc.
Why did the other 50% fail to respond? How many developed obstructive apnea? How many developed. Complications & did these require removal?
Dr. Norma Braun:
I was diagnosed with severe Obstructive Sleep Apnea in approximately 2002. I had UPPP surgery and nasal surgery for a deviated septum approximately Summer, 2003. Since my diagnoses, I could never tolerate any of the CPAP mask due to extreme Claustrophobia, PTSD and other comorbid psychological disorders. My post operative sleep study showed a significant reduction to my episodes of OSA. However, during my second post operative sleep study, I presented with Complex Sleep Apnea with severe OSA and severe hypopnea. My next option was going to be maxillomandibular advancement, genioglossus advancement, and tongue reduction surgeries. However, I delayed this option because more treatment advances in Sleep Apnea was being introduced, such as oral devices, Inspire Upper Airway Stimulation, and others. Please, is it possible for the Remede System to be used on patients with Complex Sleep Apnea? Also, is it possible for a patient to have the Inspire and Remede systems? Thank you for your anticipated response.
I have Central Apnea from a hypoxic brain injury 18 yrs ago. I also have epilepsy. I’ve been struggling soooo long with many many diff masks etc with my VPAP machine to no avail. I’m falling asleep driving. I’m waking up constantly with headaches all the time, I’m using 10 Liters of o2 when sleeping to get by & hopefully help with seizures from stopping breathing. I’m tired ALL the time. I’m getting desperate to stay awake long enough during the day to accomplish something instead of napping bcz I’m so tired all the time. Does this implant seem like something I should look into? Tx for your time.
I was diagnosed with CSA and struggle with it daily. I would like more information on the Remede system and cost of this procedure. Thanks
I have both osa and csa. About equally half and half. It is moderate to severe. Would this work for both? I have claustrophobia and hate cpap.
I have been approved for this device but my insurance (Humana) won’t approve it. Any suggestions?
I think the previous questions weren’t answered because this is magazine review and their questions are to a doctor or device supplier. Possibly research the company that supplies this implant and contact them. When I did they answered all my questions including which hospitals to contact to have this implanted.