Medical device maker ZOLL, an Asahi Kasei company, announced that its remedē System has been approved by the US Food and Drug Administration (FDA) for conditional use with magnetic resonance imaging (MRI).
ZOLL’s remedē System is an implantable transvenous phrenic nerve stimulation therapy. It is designed to treat patients suffering from moderate to severe Central Sleep Apnea (CSA).
The FDA has approved the full-body MRI for all the models of the remedē System. It will now include new remedē patients along with those who already have the device.
ZOLL Respicardia president Collin Anderson said: “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 ensure 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.”
The implantable device turns on automatically each night to stimulate the phrenic nerve, a nerve in the chest. It communicates with the diaphragm’s breathing muscles to restore more regular breathing.
In 2017, the US health regulator cleared the ZOLL’s remedē System.
The medical device maker also has the next-generation remedē EL-X System, which was approved by the FDA two years back.
remedē EL-X System has a patient-friendly design to boost functionality and simplify the implant procedure, offering more device longevity for patients with CSA.
Additionally, the device has features like reduced size, longer average battery life, stimulation and sensing from a single lead, and full-night, respiration, and device algorithm monitoring capabilities via DRēAM View.
In September 2021, the company acquired Israel-based medical device and digital health company Itamar Medical for around $538m.
