ALS NeuRx video ALS NeuRx video

 

ALS product information

What is the NeuRx Diaphragm Pacing System (DPS)®?

The NeuRx DPS® is a groundbreaking neurostimulation technology approved by the U.S. Food and Drug Administration (FDA) for treating people with both ALS and other breathing problems.

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.

The NeuRx® Clinical Station has three roles in supporting diaphragm pacing. First, it is connected to the electrodes during the procedure to provide intra-operative stimulation and sensing of stimulation response. It records the diaphragm motor points response to the intra—operative stimulation. Second, it is used to optimize, for comfort and effect, the Amplitude, Pulse Width, Pulse Frequency, Respiration Rate and Inspiration Interval post operatively. Lastly, it programs the desired settings in the NeuRx® EPG.

The PermaLoc® electrode, NeuRx DPS®, NeuRx® EPG & NeuRx® Clinical Station are manufactured by Synapse Biomedical Inc. in Oberlin Ohio. ISO 13485:2003 certified.

Statement of intended use, warnings, precautions, side effects, and contraindications