ZOLL’s Remedē System OK’ed for MRI Conditional Use

ZOLL Medical Corporation, an Asahi Kasei company, has gained U.S. Food and Drug Administration (FDA) approval of its remedē system for conditional use with MRI.
 
The remedē system is an implantable, transvenous phrenic nerve stimulation therapy to treat adults with moderate to severe central sleep apnea (CSA). The full-body approval applies to all of the remedē system’s models, covering new patients as well as those who already have the device implanted.
 
“Patients with Central Sleep Apnea often suffer from other co-morbidities that may benefit from MRI scanning including, but not limited to, brain, spine and joint issues. Approval of the remedē System for conditional use with MRI will allow those patients to now have access to this important therapy,” Dr. Asim Roy, medical director of the Ohio Sleep Medicine Institute told the press.
 
“MRI compatibility for the remedē System has a substantial positive impact for both patients and providers. Access to a wider range of imaging options is important to ensuring patients receive the best care available,” added Collin Anderson, president of ZOLL Respicardia. “Prior to this approval, the need for ongoing MRI was a contraindication for the remedē System and a concern for patients who were uncertain about their long-term healthcare needs. FDA approval to use full-body MRI on remedē patients is a significant milestone for ZOLL and the remedē therapy.”
 
The remedē system earned FDA approval in 2017. The implantable device activates automatically every night to stimulate the phrenic nerve, sending signals to the breathing muscles to help restore a more normal breathing pattern.
 
The next-gen remedē EL-X system, FDA approved in 2021, has enhanced functionality, patient-friendly design, simplifies implant procedure, and provides greater device longevity. It features longer average battery life, smaller size, stimulation and sensing from one lead, and full-night respiration and device algorithm monitoring capabilities.