This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: NeuRx Diaphragm Pacing System (NeuRx DPS)
PMA Applicant: Synapse Biomedical, Inc.
Address: 300 Artino St., Oberlin, OH 44074 US
Approval Date: March 31, 2023
Approval Letter: Approval Order
What is it?
The NeuRx Diaphragm Pacing System (DPS) uses electrical impulses to stimulate the diaphragm muscles of people with high spinal cord injuries who can no longer breathe on their own. It is used to strengthen the diaphragm muscles after they haven’t been used in a long time and then act as a breathing pacemaker to stimulate those muscles and allow for breathing without the help of a mechanical ventilator.
The main components of the system include: four implanted electrodes, a clinical station for programming, an external pulse generator, and a patient controller.
How does it work?
The NeuRx DPS electrodes are implanted into the muscles of the diaphragm during laparoscopic surgery near the nerve that controls the diaphragm, called the phrenic nerve, but without touching it or moving it. The electrode wires, or leads, run through the body to an exit site created in the chest. Outside the body, the leads are connected to an external pulse generator that controls the timing and level of diaphragm pacing stimulation. Each electrode can be controlled separately. A clinician programs the system to generate electrical current impulses to the diaphragm at a level that stimulates the muscles to expand and contract, allowing the patient to inhale and exhale.
When is it used?
The NeuRx Diaphragm Pacing System is intended for use in patients 18 years and older with stable high spinal cord injuries who lack control of the diaphragm but who will benefit from diaphragm stimulation to help them breathe without relying on a mechanical ventilator. The system can support patient breathing continuously for 4 or more hours each day.
What will it accomplish?
This type of stimulation system should give 90% of people the ability to breathe without a ventilator for at least 4 hours per day, and allow 50-60% of people to breathe without a ventilator for 24 hours each day (continuous use).
In one study of 92 people, 88% (81/92) achieved at least 4 consecutive hours of pacing from the NeuRx DPS. Additionally, 76% (70/92) of people in the study received stimulation for at least 12 hours per day and 60.8% (56/92) of participants used stimulation for 24 hours.
When should it not be used?
The NeuRx DPS should not be used for patients with diaphragms that cannot be stimulated.
Additional information (including warnings, precautions, and adverse events):