U.S. Food and Drug Administration has approved an implantable device called the Remedē System that can act as a solution for people who suffer from moderate to severe central
- USFDA has approved an
implantable device called the Remede
system to treat moderate to severe central sleep
- In central sleep apnea,
breathing stops momentarily due to failure of brain to stimulate the
- Remedē system restores the lapse in
brain signals to the diaphragm and ensures normal breathing again
The device works to
stimulate the diaphragm to produce normal breathing.
The device is implanted surgically right underneath the skin in the upper chest
area and consists of a battery pack with small thin
wires. These wires are inserted into the blood vessels in the chest near the phrenic nerve, which stimulates it
to move the diaphragm and restore normal breathing. It is thus responsible to monitor respiratory signals during sleep.
‘Moderate to severe central sleep apnea and the health hazards that arise from it may have found a cure at last with a new implantable device, thus helping people with this condition to have a good night’s sleep.’
"This implantable device offers patients
another treatment option for central sleep apnea," said Tina Kiang, Ph.D.,
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. "Patients should speak with their health care
providers about the benefits and risks of this new treatment compared to other
Apnea Sleep apnea
occurs during sleep and causes a person to have one or more pauses in breathing
or have shallow breaths.The pauses can be for a few seconds to minutes.
In central sleep apnea, the brain fails to send signals to the diaphragm to breathe, thus leading to pauses in breathing
during sleep for a period of 10 seconds or more before restarting again.
This may lead to insomnia and may result in serious health issues, including an
increased risk for high blood pressure
, heart attack
, heart failure, stroke,
obesity, and diabetes according
to the National Institute of Health's National Center on Sleep Disorders
Research. Existing common
treatment options for moderate to severe sleep apnea include medication,
positive airway pressure devices (for example, continuous positive airway pressure machine), or
Central sleep apnea is different from
obstructive sleep apnea in which the patient attempts to breathe, but the upper
airway is partially or completely blocked.
Testing of the Remede System in
The effectiveness of the Remedē System in
reducing apnea hypopnea index (AHI), a measure of the frequency and severity of
apnea episodes was assessed by the FDA.
Results obtained from the data after six
months from 141 patients was as follows
- With an active Remedē System implanted, AHI was
reduced by 50 percent or more in 51 percent of patients .
- Without an active Remedē System implanted, AHI
was reduced by 11 percent in patients.
Common adverse effects that were reported in
the study were concomitant device interaction, implant site infection and
swelling and local tissue damage or pocket erosion.
Some of the precautions to be taken with the
Remedē System is to not use it in patients with an active infection, those
known to require magnetic resonance imaging and those with obstructive sleep
The FDA granted approval of Remede System to
- FDA approves implantable device to treat moderate to severe central sleep apnea - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579506.htm)