The next-generation remedē EL-X system is designed to simplify the implant procedure and provide improved device longevity for patients with CSA
The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Zoll Medical has secured approval from the US Food and Drug Administration (FDA) for its remedē EL-X system to treat moderate to severe central sleep apnea (CSA) in adult patients.
CSA is a serious condition that may result in heart failure, coronary artery disease, and certain cardiac arrhythmias.
With enhanced functionality, the next-generation remedē EL-X system is designed simplify the implant procedure and offer improved device longevity for patients with CSA.
The new device is said to offer a 40% longer average battery life compared to an earlier version and is around 25% smaller than the previous version.
The device’s single-port system enables to offer both stimulation and sensing from a single lead. With full-night and comprehensive diagnostic capabilities, the system provides data-driven clinical insights with DRēAM View.
Zoll Respicardia president Pete Sommerness said: “The next-generation remedē System is built on the proven success of the current platform, with the needs of both patients and clinicians in mind.
“The increased longevity, smaller size, enhanced diagnostics, and simplified implant procedure will substantially benefit patients.”
The company will immediately begin the phased launch of the new remedē EL-X system in implanting centres in the US.
In 2017, the company secured FDA approval for its first-generation remedē system.
It is an implantable device designed to activate automatically each night to stimulate a nerve in the chest (phrenic nerve) to send signals to the breathing muscles (diaphragm) to help restore a normal breathing pattern.
In May this year, Zoll Medical secured an investigational device exemption (IDE) approval from the FDA to begin the feasibility study of TherOx Supersaturated Oxygen (SSO2) Therapy.