Description
The Department of Veterans Affairs is seeking to acquire four Inspire implantable pulse generators for the treatment of obstructive sleep apnea. The devices must be compatible with existing Inspire software, leads, and accessories, and must meet specific functional requirements, including battery longevity, implantable housing and materials, sensing and stimulation function, and regulatory approval. The devices will be used to support veterans with moderate to severe obstructive sleep apnea who are unable to tolerate continuous positive airway pressure therapy.
Key features of the required device include:
• Brand / Model Compatibility: Must be Inspire 5 (or latest FDA-cleared Inspire Medical Systems model) IPG compatible with existing Inspire software, leads, and accessories
• Closed / Proprietary Ecosystem: IPG must integrate seamlessly with Inspire’s sensing and stimulation leads, patient remote, and clinician programmer
• Battery Longevity: Battery must support approximately 10 years of use under standard operating conditions with low power consumption
• Implantable Housing and Materials: Constructed from biocompatible materials (e.g., titanium); safe for subcutaneous implantation below the clavicle/chest
• Sensing and Stimulation Function: Must detect respiratory effort via sensing lead and deliver synchronized electrical stimulation to hypoglossal nerve
• MRI Conditional / Imaging Safety: Device must be labeled MRI Conditional per manufacturer specifications for safe imaging procedures
• Telemetry and Programming Capability: Must support encrypted telemetry, clinician programming, and remote activation by patient controller
• Regulatory Approval and Support: Device must be FDA-approved for treatment of OSA and supported by Inspire Medical Systems for warranty and service