ZOLL developed remedē System to help treat adults with moderate to severe Central Sleep Apnea (CSA) with magnetic resonance imaging (MRI). Full-body MRI approval allows for comprehensive MRI scans to be performed on individuals who are either new remedē patients or those who already have a remedē device implanted.
The remedē System consists of an implantable device that activates automatically each night. It stimulates the phrenic nerve, which is located in the chest and sends signals to the diaphragm, the main muscle involved in breathing. By stimulating the phrenic nerve, the remedē System helps restore a more normal breathing pattern during sleep.
The next-generation remedē EL-X System is designed to provide enhanced functionality and improve the experience for patients with Central Sleep Apnea (CSA). It offers a patient-friendly design that simplifies the implant procedure and promotes greater longevity of the device. Some of its key features include patient-friendly design, simplified implant procedure, longer battery life, reduced size, single lead for stimulation and sensing and full-night monitoring capabilities.
CSA is a significant breathing disorder that disrupts the normal breathing pattern during sleep, leading to poor sleep quality and overall well-being. It occurs when the brain fails to send appropriate signals to stimulate the respiratory muscles for breathing. Many individuals with CSA also have heart disease, particularly heart failure, which further increases their risk of hospitalizations and adverse outcomes, including death.
US Food and Drug Administration (FDA) has approved the remedē System for conditional use with magnetic resonance imaging (MRI).
