Battery implant approved to treat sleep apnea

pharmafile | October 9, 2017 | News story | Sales and Marketing |  FDA, biotech, drugs, pharma, pharmaceutical 

The FDA has announced the approval of a new form of treatment for central sleep apnea, in the form of an implantable device that stimulates the nerve to kick-start the body to breathe. Though it sounds uncomfortable invasive, the device is preferable to the serious health risks those with sleep apnea face.

Central sleep apnea differs from the more commonly known obstructive sleep apnea, where the upper airway is blocked leading to loud snoring, by the fact that it is caused by the brain failing to send the signal to the muscles that control breathing.

This leads to pauses in breathing during sleep of potentially more than 10 seconds at a time, at a rate of more than 30 times per hour. It can lead to a number of health issues, including an increased risk for high blood pressure, heart attack and stroke.

At present, treatments are usually limited to medication, surgery or onerous positive airway pressure devices. The new device offers a benefit over such methods, as the Remedē System is a battery park placed under the skin with wires inserted into blood vessels in the chest, which act to stimulate the phrenic nerve.

The device works by monitoring the action of the nerve and, when signals from the brain fail to stimulate breathing, the device steps in to encourage normal respiration.

In clinical trials from the owner of the system, Respircardia, half of participants implanted with the device showed reduced severity and frequency of apnea episodes, as measured by the apnea hypopnea index.

“This implantable device offers patients another treatment option for central sleep apnea,” said Tina Kiang, 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 available treatments.”

Ben Hargreaves