FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: NeuRx Diaphragm Pacing System™
Manufacturer: Synapse Biomedical, Inc.
Address: 300 Artino Street, Cleveland, Ohio 44074
Approval Date: September 28, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/h100006a.pdf
What is it? The NeuRX Diaphragm Pacing System™ helps people breathe who have both amyotrophic lateral sclerosis (ALS) and breathing problems.
How does it work? The NeuRX Diaphragm Pacing System™ is implanted using a device with a camera at the end of it (laparoscope) in an outpatient procedure. The System consists of four electrodes that are implanted in the breathing muscle (diaphragm), a fifth electrode that is implanted under the skin, an electrode connector, which groups the five electrodes exiting the skin into a socket, a holder to hold the electrode connector in place on the skin, and a battery-powered stimulator box (an external pulse generator - EPG). The stimulator box sends electrical signals to the diaphragm replacing the signals normally sent by the brain along the nerves. The signals cause the diaphragm to contract, which helps to condition and exercise the muscle. The EPG settings are adjusted by the physician to match the patient’s normal breathing pattern. The patient controls the EPG by turning it on and off by pressing two buttons in front of the EPG. No other controls are available or necessary to operate the device.
When is it used? The NeuRx Diaphragm Pacing System (DPS) ™ is used in patients who have amyotrophic lateral sclerosis (ALS) patients and breathing problems.. A patient’s diaphragm must show its ability to respond to stimulation. The device is used in patients 21 years of age or older.
What will it accomplish? It will help ALS patients breathe longer without the aid of a ventilator.
When should it not be used? The NeuRx Diaphragm Pacing System should not be used in ALS patients who are able to breathe on their own and without the need for mechanical support.
Additional information: SSPB and Labeling will be available online.