Synapse Biomedical has received the US Food and Drug Administration (FDA) approval for its NeuRx Diaphragm Pacing System (DPS) to treat amyotrophic lateral sclerosis (ALS).
The FDA Humanitarian Device Exemption (HDE) marketing approval is based on the positive results from a multicenter clinical trial that enrolled 106 patients and treated chronic hypoventilation patients.
NeuRx DPS is a four-channel, battery-powered external pulse generator (EPG) with electrodes that are implanted through minimally invasive laparoscopic surgery.
The device provides electrical signals which stimulate the diaphragm, causing a contraction of muscle and nerves of the diaphragm.
The Diaphragm Pacing System is also approved in the US under an HDE for spinal cord injury (SCI) patients who have stimulatable diaphragms but lack control of their diaphragms.
Synapse Biomedical president and CEO Anthony Ignagni said they are pleased that the FDA approved this next indication for use of the NeuRx DPS to treat respiratory problems in ALS.
"In granting approval, it allows us to now offer individuals living with ALS more time to be able to breathe with their own muscles," Ignagni said.