FDA clears diaphragm system to treat Lou Gehrigs disease

The FDA has approved Synapse Biomedical’s NeuRx Diaphragm Pacing System (DPS), used for treatment of patients with Amyotrophic Lateral Sclerosis (ALS)—Lou Gehrig’s disease—who have stimulatable diaphragms and are experiencing chronic hypoventilation.

The NeuRx DPS was cleared under the FDA Humanitarian Device Exemption marketing approval, based on demonstration that the device could help ALS patients live longer and sleep better. The findings were the result of a multicenter clinical trial that enrolled 106 patients and treated 86 for chronic hypoventilation, according to a company statement.

Amyotrophic lateral sclerosis is an incurable and fatal neuromuscular disease in which progressive muscle weakness results in paralysis. As the phrenic nerve to the diaphragm muscle fails, patients lose the ability to breathe without ventilator support. There are currently 30,000 people in the U.S. with ALS, and more than 5,600 new cases are diagnosed each year.

The NeuRX DPS is implanted through minimally invasive laparoscopic surgery and provides electrical stimulation to the diaphragm muscles. Repeated use of the device conditions the muscles, delaying respiratory failure and need for tracheotomy and mechanical ventilation, according to the Oberlin, Ohio-based Synapse.