Zoll Medical, an Asahi Kasei company, announced today that the FDA has approved its next-gen Remedē EL-X implantable neurostimulation system to treat severe sleep apnea.
Zoll acquired the technology through its acquisition of Respicardia in April.
Improvements to the new Remedē EL-X include:
- 40% longer average battery life versus the previous version;
- Three-fourths the size of the previous version;
- A single lead, single-port system providing both stimulation and sensing from a single lead;
- Data-driven clinical insights with Drēam View, which includes 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,” Pete Sommerness, president of Zoll Respicardia, said in a news release. “The increased longevity, smaller size, enhanced diagnostics, and simplified implant procedure will substantially benefit patients.”
The company has started a phased launch of the Remedē EL-X in U.S. implanting centers.