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ZOLL Announces Approval of Next-Generation Remedē System for the Treatment of Central Sleep Apnea

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ZOLL Announces Approval of Next-Generation Remedē System for the Treatment of Central Sleep Apnea | Pharmtech Focus

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. 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:

  • 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,” 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.

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