Respicardia wins FDA nod for Remedē central sleep apnea neurostim device

Respicardia said today that it won FDA approval for its Remedē transvenous implantable neurostimulation system designed to treat patients with central sleep apnea.

Central sleep apnea occurs when the brain fails to control breathing during sleep, unlike the more common obstructive sleep apnea which consists of a partially collapsed airway which causes pauses in breathing, Respicardia said.

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.

“This implantable device offers patients another treatment option for central sleep apnea. Patients should speak with their health care providers about the benefits and risks of this new treatment compared to other available treatments,” FDA CDRH anesthesiology, general hospital, respiratory, infection control and dental devices acting director Tina Kiang said in a prepared FDA release.

Approval of the device came based off data from the Minnetonka, Minn.-based company’s pivotal trial of the device, which had results published in the Lancet last September.

The 151-patient, 31-hospital study aimed to explore the safety and effectiveness of a transvenous phrenic nerve stimulator which is designed to send regular signals to get the diaphragm to breathe during sleep.

At 6-months, the number of CSA events per hour were reduced by 50% or more for 51% of the members in the treatment group, according to the report. Only 8 members in the control group achieved the same reduction. Improvements were also noted in reducing time spent with low blood oxygen levels.

“The patients at our center treated with the remedē System experienced outstanding results and significant reduction in their CSA symptoms. Having a therapeutic option for patients with CSA that automatically provides therapy and works throughout the night is a breakthrough treatment for this serious breathing disorder,” pivotal trial principal investigator Dr. Maria Rosa Costanzo said in a press release.

“We are thrilled the remedē System received FDA approval and are excited to provide this safe and effective therapy that is proven to improve the quality of life for CSA patients. This is a significant step forward in our efforts to offer clinicians a breakthrough and effective treatment option for their patients with CSA,” prez & CEO Bonnie Labosky said in a prepared statement.

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