A major April 2023 development for the spinal cord injury community came with the announcement that Synapse Biomedical received FDA premarket approval for its NeuRx Diaphragm Pacing System (DPS) for use in people with spinal cord injuries who rely on mechanical ventilation.
For individuals with high cervical SCI, damage to the spinal cord can interrupt communication between the brain and the diaphragm, making independent breathing difficult or impossible. Mechanical ventilation can be lifesaving, but long-term dependence carries physical, emotional, and logistical burdens.
The NeuRx system addresses this by electrically stimulating the diaphragm muscle to trigger breathing. Electrodes are implanted minimally invasively and connected to an external pulse generator that activates the diaphragm rhythmically. In some cases, this can reduce time spent on ventilators or allow users to transition away from full-time mechanical ventilation.
What made the April 2023 announcement especially important was the FDA approval pathway. Previously, access was more limited under a Humanitarian Device Exemption. Full premarket approval meant the device could become more widely available in hospitals throughout the United States, potentially simplifying adoption and reimbursement.
Advocates described the approval as a meaningful quality-of-life breakthrough. Greater breathing independence can improve mobility, speech, sleep quality, and reduce respiratory complications—one of the leading causes of illness in people with cervical SCI.
The story represented an important reminder that SCI innovation is not only about restoring walking. Respiratory technologies can have enormous real-world impact, especially for those living with the highest-level injuries.
