Synapse Biomedical has been granted FDA approval to market its NeuRx Diaphragm Pacing System (DPS) for the treatment of ALS.
The device, which was granted a Humanitarian Use Device designation last year, can help ALS patients who are experiencing respiratory problems and whose phrenic nerve to the diaphragm is still intact. Following implantation, the NeuRx DPS stimulates the diaphragm to help patients breathe without a ventilator.
From the product page:
The NeuRx DPS® consists of:
- Four PermaLoc® electrodes implanted in the diaphragm
- A fifth electrode implanted under the skin
- An electrode connector, which groups the five electrodes exiting the skin into a socket
- An external pulse generator (EPG)
- A removable cable to connect the electrode socket to the EPG
With no moving parts, noiseless operation and small size, the state-of-the-art NeuRx DPS® is engineered to help you to breathe.
The electrodes are designed using 316 Stainless Steel and other biocompatible materials with a long history of implantation. The design of the PermaLoc® electrode has been developed with anchoring technology specifically for long term implantation into the diaphragm muscle and laparoscopic delivery.
NeuRx® EPG is a stimulator box that sends electrical signals to the diaphragm, replacing the signals normally sent by your brain along your nerves. The signals cause the diaphragm to contract, which conditions and exercises the muscle. The EPG settings are adjusted by your doctor to match your natural and comfortable breathing pattern. You control the NeuRx DPS® EPG. You turn it on and off by pressing the two buttons on the front of the EPG. Because the EPG is noiseless and about the size of a TV remote, it can be easily concealed.
Product page: NeuRx Diaphragm Pacing System (DPS)®