NeuRx DPS RA/4 Respiratory Stimulation System, FDA-Approved

Filed in archive FDA Approvals , Medical Devices , News on June 18, 2008

An implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator - NeuRx DPS RA/4 Respiratory Stimulation System - has been approved by the US FDA.

Patients with severe spinal cord injuries who cannot control their diaphragms often need mechanical ventilation to help them breathe. This usually requires a full-time connection to a ventilation machine.

The NeuRx DPS RA/4 uses four electrodes implanted in the muscle of the diaphragm to electronically stimulate contraction; this stimulation allows the patient to inhale.

The FDA approved the distribution of this device under a Humanitarian Device Exemption, an approval process for devices intended to treat or diagnose conditions that affect fewer than 4,000 people per year.

NeuRx DPS RA/4 Respiratory Stimulation System is manufactured by Synapse Biomedical.

Source: FDA News