ZOLL remedē System receives FDA approval for sleep apnoea treatment
Betsy Goodfellow | May 25, 2023 | News story | Medical Communications | Ear Nose & throat, FDA, ZOLL, sleep apnoea
ZOLL Medical Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) for its remedē System for conditional use with magnetic resonance imaging (MRI) for the treatment of moderate to severe Central Sleep Apnoea (CSA).
The remedē System, an implantable device originally approved by the FDA in 2017, automatically activates each night, stimulating the phrenic nerve in the chest and sending signals to the diaphragm in order to restore a normal breathing pattern.
Dr Asim Roy, medical director of the Ohio Sleep Medicine Institute, US, commented: “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.”
Collin Anderson, president of ZOLL Respicardia, added: “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. 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.”
Betsy Goodfellow
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