Zoll Medical announced that it received FDA approval for its Remedē system for conditional use with magnetic resonance imaging (MRI).
Chelmsford, Massachusetts-based Zoll designed its Remedē system as an implantable, transvenous phrenic nerve stimulation therapy. It treats adults with moderate to severe central sleep apnea (CSA). Full-body MRI approval applies to all models of the system and covers new patients as well as existing ones.
Dr. Asim Roy, medical director of the Ohio Sleep Medicine Institute, said in a news release that CSA patients often suffer from other co-morbidities. These comorbidities may benefit from MRI scanning, including brain, spine and joint issues.
Remedē initially received FDA approval in 2017. The implantable device activates automatically each night to simulate the phrenic nerve in the chest. This sends signals to the diaphragm to help restore a more normal breathing pattern.
Zoll won FDA approval for the next-generation Remedē El-X system in 2021. This version combines enhanced functionality with a patient-friendly design and greater device longevity. It features longer average battery life, reduced size and stimulation and sensing from a single lead. The system also has full-night respiration and device algorithm monitoring capabilities.
“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,” said 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.”