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Zoll’s sleep apnea therapy receives FDA approval 

Zoll Medical has announced that it has obtained FDA approval for the conditional use of its Remedē system in conjunction with magnetic resonance imaging (MRI). The Remedē system, developed by Zoll and based in Chelmsford, Massachusetts, is designed as an implantable therapy that stimulates the phrenic nerve through transvenous means. It is intended for the treatment of moderate to severe central sleep apnea (CSA) in adults. The recent FDA approval covers the use of full-body MRI for all models of the Remedē system, including both new and existing patients.

Dr. Asim Roy, the medical director of the Ohio Sleep Medicine Institute, explained in a news release that CSA patients often experience other health issues, known as comorbidities, which could benefit from MRI scanning. These comorbidities include problems related to the brain, spine, and joints.

The Remedē system initially received FDA approval in 2017. The implantable device is designed to activate automatically each night, stimulating the phrenic nerve in the chest and sending signals to the diaphragm, thus aiding in the restoration of a more normal breathing pattern.

In 2021, Zoll obtained FDA approval for the next-generation Remedē El-X system. This updated version combines improved functionality with a patient-friendly design and increased device longevity. It offers a longer average battery life, a smaller size, and stimulation and sensing capabilities through a single lead. The system also includes features such as full-night respiration and device algorithm monitoring.

Collin Anderson, the president of Zoll Respicardia, emphasized the positive impact of MRI compatibility for the Remedē system on both patients and healthcare providers. Access to a wider range of imaging options is crucial to ensuring that patients receive the best possible care. Anderson described the approval for full-body MRI usage in Remedē patients as a significant milestone for Zoll and the Remedē therapy, as it addresses the concerns of patients who were uncertain about their long-term healthcare needs due to the previous contraindication for ongoing MRI scans.

 

© Zoll Medical Corporation

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