6515--FY26-IMPLANTABLE PULSE GENERATOR INTENT TO SOLE SOURCE

lant delivers mild electrical stimulation to the hypoglossal nerve during sleep, maintaining airway patency and preventing apneic events. The VA intends to enter a sole source arrangement for this requirement via Inspire Medical Systems Inc. Salient Characteristics for Inspire 5 implants: Functional Requirements Characteristic Requirement / Minimum Acceptable Rationale / Verification Brand / Model Compatibility Must be Inspire 5 (or latest FDA-cleared Inspire Medical Systems model) IPG compatible with existing Inspire software, leads, and accessories. Ensures interoperability with existing Inspire ecosystem and avoids incompatibility issues. Closed / Proprietary Ecosystem IPG must integrate seamlessly with Inspire s sensing and stimulation leads, patient remote, and clinician programmer. Maintains manufacturer warranty and compliance; substitutes not compatible. Battery Longevity Battery must support approximately 10 years of use under standard operating conditions with low power consumption. Reduces need for replacement surgery and long-term maintenance cost. Implantable Housing and Materials Constructed from biocompatible materials (e.g., titanium); safe for subcutaneous implantation below the clavicle/chest. Ensures patient safety, comfort, and biocompatibility. Sensing and Stimulation Function Must detect respiratory effort via sensing lead and deliver synchronized electrical stimulation to hypoglossal nerve. Critical for airway patency and therapeutic efficacy. MRI Conditional / Imaging Safety Device must be labeled MRI Conditional per manufacturer specifications for safe imaging procedures. Allows veteran patients to receive diagnostic imaging safely. Telemetry and Programming Capability Must support encrypted telemetry, clinician programming, and remote activation by patient controller. Allows secure follow-up, therapy adjustment, and device monitoring. Regulatory Approval and Support Device must be FDA-approved for treatment of OSA and supported by Inspire Medical Systems for warranty and service. Ensures safety, compliance, and quality assurance under VA standards. Lead and Software Compatibility Must connect with Inspire sensing and stimulation leads, previously purchased Inspire software, and programming cable. Protects prior government investment and maintains system integrity. Procedure and Recovery Alignment Design should allow for standard outpatient implantation (~60 90 minutes) via small incisions with minimal recovery. Supports efficient OR scheduling and patient throughput. Safety and Performance Monitoring Must include impedance and waveform monitoring for post-implant checks and malfunction detection. Reduces patient risk and improves quality control. PERIOD OF PERFORMANCE: The product is requested to be delivered no later than December 16, 2025.