Synapse Biomedical out of Oberlin, Ohio has received the Humanitarian Use Device (HUD) designation for use of its NeuRx Diaphragm Pacing System on ALS patients with “a stimulatable diaphragm who are experiencing chronic hypoventilation.” The device electrically stimulates the diaphragm to contract and expand, bringing back breathing to some of those that would otherwise be stuck to a ventilator. Two years ago the system was approved by the FDA for people with spinal cord injury and it has approval in Europe for diaphragm dysfunction. The latest FDA designation allows the company to seek a Humanitarian Device Exemption for the NeuRx system.
The NeuRx DPS™ is a four-channel battery-powered external pulse generator (EPG) with electrodes that are implanted through minimally invasive laparoscopic surgery to provide electrical stimulation to the muscle and nerves of the diaphragm, the principal breathing muscle.
During the procedure, a surgeon creates four dime-size holes in the abdominal region and inserts a laparoscope so the diaphragm muscle can be seen. The surgeon then places small electrodes in the diaphragm. The electrodes are attached to the EPG that stimulates and causes a contraction of the diaphragm. The ALS surgery is typically done on an outpatient basis.
Post-operatively, the EPG is programmed and the patients and caregivers are trained on the use of the NeuRx DPS™.
Press release: Synapse Biomedical Receives FDA Humanitarian Use Device Designation for Amyotrophic Lateral Sclerosis (ALS)…
Product page: NeuRx DPS…
Flashback: Electric Muscle Stimulation with NeuRx Diaphragm Pacer