Asahi Kasei company Zoll Medical has received approval from the US Food and Drug Administration (FDA) for its remedē system for conditional use with magnetic resonance imaging (MRI).
The remedē system is an implantable transvenous phrenic nerve stimulator intended to treat patients who are experiencing moderate to severe central sleep apnea (CSA).
The approval for use with full-body MRI covers all models of the remedē system, encompassing both new patients adopting the remedē device and existing users.
Zoll Respicardia president Collin Anderson said: “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.”
In 2017, the company received approval from the FDA for its remedē system, which automatically activates each night to stimulate a phrenic nerve in the chest.
This stimulation then sends signals to the breathing muscles (diaphragm), which consequently helps restore a more regular breathing pattern.
In 2021, the regulator approved the next-generation remedē EL-X system that integrates improved functionality with a patient-friendly design to simplify the implant procedure and offer increased device longevity for CSA patients.
Reduced size, longer average battery life, stimulation and sensing from a single lead, as well as full-night, respiration and device algorithm monitoring capabilities through DRēAM View, are some of the benefits of the remedē EL-X system.