Expanded approval enables the use of magnetic resonance imaging (MRI) with both implants at 3.0 Tesla (3%). Patients implanted with the neuromodulation systems for obstructive sleep apnea (OSA) can now undergo high-resolution 3T MRI scans under specific conditions.
The FDA approved expanded, full-body compatibility for 1.5T scans in July 2022. This approval enables even stronger, higher-resolution imaging for users of Inspire therapy.
According to Inspire, 3T scans represent some of the most powerful and commonly used imaging modalities in hospitals today. They produce detailed images of the brain, spine, joints, prostate, and other critical structures.
“We are excited to expand access to some of the most advanced imaging technology in modern medicine,” Inspire Medical Systems, Inc., Chairman and CEO Tim Herbert said. “MRI compatibility is an important milestone to achieve. We hope this further strengthens long-term confidence in Inspire therapy for both patients and clinicians.”
Inspire therapy comes from implantable, pacemaker-like devices that deliver mild electrical stimulation to the hypoglossal nerve, which controls tongue muscles, to treat OSA. It delivers gentle pulses with each breath to move the tongue and keep the airway open.
The system first received FDA approval in 2014, going through multiple iterations before the previous generation, IV, and the latest edition, Inspire V. The Inspire V next-generation sleep apnea therapy system launched in the U.S. last year. It features a next-generation neurostimulator and associated Bluetooth patient remote and physician programmer. The system’s closed-loop, internal sensing feature eliminates the need for a pressure-sensing lead.
