FDA grants MRI conditional use for implantable sleep apnea therapy

The FDA has granted conditional use with MRI to an implantable transvenous phrenic nerve stimulation therapy for adults with moderate to severe central sleep apnea.

According to a press release from Zoll, its remed System full-body MRI approval applies to all models and covers both new patients and those who already have a device.

“Prior to this approval, the need for ongoing MRI was a contraindication for the remed System and a concern for patients who were uncertain about their long-term health care needs,” Collin Anderson, Zoll president, said in the release. “Access to a wider range of imaging options is important to ensuring patients receive the best care available.”

The remed System, which was approved by the FDA in 2017, is activated automatically each night to stimulate a nerve in the chest that transmits signals to breathing muscles, prompting more normal breathing patterns. An updated model, the remed EL-X System, gained FDA approval in 2021 and provides improved functionality, with a simplified implant procedure and greater device longevity for users.

“Patients with central sleep apnea often suffer from other comorbidities that may benefit from MRI scanning including, but not limited to, brain, spine and joint issues,” Asim Roy, MD, medical director of the Ohio Sleep Medicine Institute, said in the release. “Approval of the remed System for conditional use with MRI will allow those patients to now have access to this important therapy.”