New Implant Approved for Moderate to Severe Central Sleep Apnea

New Device Approved for Central Sleep Apnea

Remede System Approved for Central Sleep Apnea

The FDA approved a new implant for patients called The Remede System.

Sleep apnea is a disorder that causes individuals to have one or more pauses in breathing or shallow breaths during sleep.

Sleep apnea (where your brain doesn't properly send breathing signals while resting) is terrible enough by itself, but the solutions to it can be scary: you may have to take medication, rely on ungainly breathing machines or opt for invasive surgery. It monitors a person's breathing signals while they are asleep and, if needed, triggers the phrenic nerve to send signals to the diaphragm so that normal respiration can be restored.

Central sleep apnea may be the result of heart failure, stroke, or other medical conditions.

The Remedē system consists of a surgically placed battery packa nd thin wires inserted into the blood vessels in the chest near the phrenic nerve, which it stimulates to engage the diaphragm to restore natural breating during sleep and improve patient quality of life and satisfaction. The Remede 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.

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The efficacy of the Remedē System was based on a study of 141 patients; the study evaluated the effectiveness of the system in reducing the apnea hypopnea index (AHI).

Adverse events most commonly reported included concomitant device interaction, infection at the site of implantation and swelling and local tissue damage or pocket erosion.

"The patients at our center treated with the remedē System experienced outstanding results and significant reduction in their CSA symptoms". AHI was reduced by 11 per cent in patients without an active Remede System implanted. The system should not be implanted in people with an active infection or among people who require use of a magnetic resonance imaging machine, the FDA said. Food and Drug Administration announced it has approved a new implantable device for patients with moderate to severe central sleep apnea.

The system is produced by Respicardia Inc., based in Minnetonka, Minnesota.

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