On May 24, 2023, Zoll announced the FDA has approved the remedē System for conditional use with magnetic resonance imaging (MRI). The implantable transvenous phrenic nerve stimulation therapy is a treatment for adults with moderate to severe central sleep apnea (CSA).
About the remedē System
The remedē System is an implantable device that automatically activates each night to stimulate the phrenic nerve in the chest that sends signals to the diaphragm to help restore a more normal breathing pattern. It is a battery-powered device placed under the skin in the upper chest with thin wire leads to deliver therapy and sense breathing. It is placed during a minimally invasive outpatient procedure by a cardiologist.
The new indication of the remedē System for conditional use with MRI makes the system available to patients who have a regular need for MRI imaging or may require an MRI in the future.
According to Zoll’s press release, the full-body MRI approval applies to all models of the remedē System.
About central sleep apnea
CSA is a breathing disorder characterized by a reduction or cessation of breathing effort during sleep, often stemming from issues in the brain or heart. Unlike obstructive sleep apnea, CSA is not caused by airway blockage, making it less common, and it can also be induced by certain medications such as pain medications.
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