FDA Clears Conditional MRI Use for Implantable Sleep Apnea System

The Food and Drug Administration (FDA) has expanded the 510(k) clearance for the remede® System (Zoll Medical Corporation), an implantable therapy for central sleep apnea, to include conditional use with magnetic resonance imaging (MRI).

An implantable transvenous phrenic nerve stimulation therapy, the remede System originally received FDA clearance in 2017 for the treatment of adults with moderate to severe central sleep apnea. The expanded FDA clearance allows the conditional use of full-body MRI for all models of the remede System, according to Zoll Medical Corporation.

Asim Roy, M.D., said the expanded FDA clearance for conditional MRI use, is a significant development for those with sleep apnea and other comorbidities.

“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,” noted Dr. Roy, the medical director of the Ohio Sleep Medicine Institute in Dublin, Ohio. “Approval of the remede System for conditional use with MRI will allow those patients to now have access to this important therapy.”

(Editor’s note: For related content, see “SNMMI Meeting: New Cardiac PET Study Shows that Severe Obstructive Sleep Apnea Doubles the Risk of Impaired Myocardial Blood Flow.”)