FDA OKs Inspire Medical’s Next-Gen Sleep Apnea Neurostimulation

Inspire Medical Systems has received U.S. Food and Drug Administration (FDA) clearance for its Inspire V therapy system to treat obstructive sleep apnea (OSA).
 
The next-gen system features a new neurostimulator and associated Bluetooth patient remote and physician programmer.
 
Inspire Medical said it’s focusing on operational readiness. This includes product manufacturing and establishing inventory levels to support a full commercial launch in the U.S.
 
The company is targeting a soft launch of Inspire V in late 2024, with full launch in 2025.
 
“We are thrilled to announce the FDA approval of our next generation Inspire neurostimulation system,” said Tim Herbert, chairman and CEO of Inspire Medical Systems. “The FDA approval marks a key milestone for the future of Inspire therapy and reinforces the many years of hard work by our team members.”
 
Last month, the company earned EU MDR approval for full-body MRI scan conditions with the Inspire OSA therapy. The approval expanded its use labeling, which was previously limited to head, neck, and extremity MRI scans. That approval is retroactive, applying to patients with the Inspire IV neurostimulator device already in place.
 
Inspire’s proprietary Inspire therapy is the first and only FDA, EU MDR, and PDMA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.