The US Food and Drug Administration (FDA) has approved ZOLL Medical Corp‘s remedē EL-X System to treat moderate to severe central sleep apnea in adult patients. The first-generation remedē System was approved by the FDA in 2017.
The next-generation remedē EL-X System features enhanced functionality, simplifies the implant procedure, and provides greater device longevity.
Features of the next-gen system include:
- Extended longevity: 40% longer average battery life versus previous version
- Reduced size: Approximately 25% smaller than the previous version
- Simplified implant: Single lead, single-port system that provides both stimulation and sensing from a single lead
- Data-driven clinical insights with DRēAM View: Enhancements include full-night, comprehensive diagnostic capabilities.
“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,” says Pete Sommerness, president of ZOLL Respicardia, in a release. “The increased longevity, smaller size, enhanced diagnostics, and simplified implant procedure will substantially benefit patients.”
Todd Goblish, vice president of research and Development at ZOLL Respicardia, says in a release, “We are very excited to offer DRēAM View, a full-night diagnostic report that will allow clinicians deeper insight into how the patient is responding to remedē therapy. DRēAM View diagnostics will enable clinicians to better tailor therapy settings for each individual patient.”
A phased launch of the remedē EL-X System will commence immediately in implanting centers in the United States.