remedē EL-X System System FDA Approval

remedē El-X System Next Generation Approval

ZOLL^® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that it has received U.S. Food and Drug Administration (FDA) approval for the remedē^® EL-X System to treat moderate to severe Central Sleep Apnea (CSA) in adult patients.¹ CSA is a serious condition that is often associated with heart failure, coronary artery disease, and certain cardiac arrhythmias.

The next-generation remedē EL-X System combines enhanced functionality with a patient-friendly design, simplifying the implant procedure and providing greater device longevity for patients with Central Sleep Apnea. Features of the new device include:¹

• Extended longevity: 40% longer average battery life versus previous version²
• 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,” said Pete Sommerness, President of ZOLL Respicardia. “The increased longevity, smaller size, enhanced diagnostics, and simplified implant procedure will substantially benefit patients.”

“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,” added Todd Goblish, Vice President of Research and Development at ZOLL Respicardia. “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.

The remedē System and Central Sleep Apnea

The first-generation remedē System was approved by the FDA in 2017. The remedē System is an implantable device that activates automatically each night to stimulate a nerve in the chest (phrenic nerve) that sends signals to the breathing muscles (diaphragm) to help restore a normal breathing pattern.³ The Post Approval Study followed patients from the pivotal trial through five years post implant.

Central sleep apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects sleep quality, quality of life, and is associated with poor outcomes. CSA results from the brain’s inability to send appropriate signals to the respiratory muscles to stimulate breathing. Many patients with CSA also have heart disease, especially heart failure.⁴ Patients with CSA and heart failure are at increased risk for hospitalizations and even death.^5,6

References

¹ FDA PMA P160039, Supplement 006, Physician Manual.
² Under normal use settings
³ Costanzo M.R., et al. The Lancet. 2016;388:974–82.
⁴ Bekfani T, Abraham WT. Europace. 2016;18(8):1123–34. Epub 2016 May 26.
⁵ Khayat R, et al. J Card Fail. 2012;18:534–40.
⁶ Khayat, R et al. European Heart J. 2015;36 1463–69.