Synapse Biomedical has received the US Food and Drug Administration's (FDA) Humanitarian Use Device (HUD) designation for its NeuRx Diaphragm Pacing System (DPS) to treat amyotrophic lateral sclerosis (ALS) patients.
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.
The HUD designation establishes that the NeuRx DPS is a medical device intended to benefit patients for treating a number of respiratory insufficiency conditions with minimally invasive neurostimulation technology.
In ALS, the NeuRx DPS provides electrical stimulation to the diaphragm muscles and continues to exercise the muscles, in an attempt to delay diaphragm atrophy and the need for invasive mechanical ventilation.
Synapse president and chief executive officer Anthony Ignagni said that in efforts to help people with the disease, they are using and focusing every available resource to help advance the availability of the NeuRx treatment, and having obtained HUD designation and filed their HDE application for ALS, they are planning to seek Continued Access approval for their clinical trial centers.