Diaphragm Stimulator for SCI

Synapse NeuRx Diaphragm Pacing System bg

NeuRx® Diaphragm Pacing

The NeuRx® Diaphragm Pacing System is designed as an alternative treatment for patients with spinal cord injuries that result in the reliance on a ventilator to breathe.

Initially in a patient suffering from a spinal cord injury, the stimulation from the NeuRx® DPS works to condition their diaphragm muscle, which has weakened from a lack of use due to their injury.

In Synapse BioMedical’s clinical trial of 50 high-level spinal cord injury / quadriplegia patients implanted with the NeuRx® DPS.

  • 100% success rate in achieving tidal volumes in patients with intact phrenic nerve.
  • 25 patients achieved full-time diaphragm pacing and eliminated the use of their ventilator.
  • 33 patients paced more than 12 hours per day and significantly reduced the time spent on their ventilator.
The NeuRx DPS® has dramatically improved comfort levels for Spinal Cord Injury Patients.

  • Reduce and in some cases eliminate their dependency on mechanical ventilators
  • Regain their independence by enhancing their mobility and transportation options
  • Allow them to sleep more comfortably and soundly without constant ventilator noise
  • May allow for natural breathing through the nose and mouth rather than primarily through tracheostomy tube

Patient Information

What is the NeuRx Diaphragm Pacing System™ and how does it improve the way an SCI patient breathes?

Unlike a mechanical ventilator, the NeuRx DPS™ provides a gentle, rhythmic, electrical stimulation to your diaphragm, causing it to contract. Initially in an SCI patient, this stimulation works to exercise and strengthen your diaphragm muscle, which had weakened while you were on a ventilator. You will begin taking deeper breaths for longer periods of time. With the assistance of the NeuRx DPS™, the breaths you take are similar to a natural, comfortable breathing pattern. This enables many SCI patients to regain their sense of smell and taste. The system can achieve long-term replacement of positive pressure mechanical ventilation for SCI patients with intact phrenic nerves.

The NeuRx DPS™ consists of:

  • Four electrodes implanted in the diaphragm
  •  A fifth electrode to complete the electrical circuit
  • A connector holder
  • A cable
  • A small, external, battery-powered pulse generator

Your caregiver controls the NeuRx DPS™ and can turn the device on and off when you choose. When it is off for extended periods, you will likely need to return to positive pressure ventilation support. The settings are defined by a trained clinician and can only be adjusted by them. The easily-concealed pulse generator provides stimulus timing and control in order to regulate movement of your diaphragm and optimize respiration.

How is the NeuRx DPS™ implanted?
A simple, minimally invasive outpatient procedure is used to implant the device’s four biocompatible electrodes, two in each side of your diaphragm. To find the best locations, your surgeon will test a number of areas on the underside of your diaphragm. This is accomplished with a special mapping instrument that stimulates the diaphragm’s surface. The fifth electrode is placed just below the skin near the exit site of the other electrodes. Only a few stitches are needed to close the small incisions. The entire procedure lasts approximately 90 minutes.
What happens after surgery?
After implantation, a doctor will work with you to determine comfortable stimulation settings that will maximize your diaphragm’s performance. The device’s settings can only be adjusted by a trained clinician.

Prior to discharge, you will receive specific conditioning instructions from your care team. You may be instructed by your physician not to use the NeuRx DPS™ right away to allow your body time to heal from surgery.

The initial conditioning sessions last as long as you can tolerate being off the ventilator, which depends on how weak your diaphragm is. During a conditioning session, your caregiver will turn on the NeuRx DPS™ and then remove you from the ventilator. Your caregiver will measure your oxygen level with a finger clip on a pulse oximeter or may measure the amount of air you are breathing with a handheld device called a Wright Respirometer. A pulse oximeter and Wright Respirometer are not essential to conditioning and may not be available in your payer plans. You should check with your insurance provider.

Your care team will instruct you on the number and duration of your conditioning sessions. To maximize your progress, record the time you remain on the pacing system at each session.

How do I know the NeuRx DPS™ will work for me?
Your doctor can help you decide if the device is appropriate for you. The typical indication is for those spinal cord injured patients dependent on mechanical ventilation for all or part of the day. Even though the electrodes are placed in the diaphragm, patients must have an intact phrenic nerve from the spinal cord to the diaphragm. Your doctor will use your history and possibly an electromyogram (EMG) along with a radiology study to determine if the nerves that run from your neck to your diaphragm are still functioning. At times the only way to know if the system will work is during the mapping part
of the laparoscopic procedure. The diaphragm has to move with stimulation for the NeuRx DPS™ to be effective.
What is the NeuRx Diaphragm Pacing System’s® proof of performance?
Each SCI patient’s success with the NeuRx® DPS varies. Yours will depend upon your physical condition, your motivation to reduce your reliance on positive pressure ventilation, and the support of your caregivers.
What NeuRx DPS® Patients Are Saying

The Pacer has changed my life tremendously. I haven’t had a single problem with the pacer and it has for sure given me a better quality of life. – Adam Booker

The pacer has allowed me to do many things that I never thought I would be able to do again. It really has enhanced my life. – Heather Johnson

Without having tubes on my chest and not hearing the constant noise from the ventilator, I feel much more like a person and less like a machine. – Joel Vander Molen

The competent and compassionate service that I have received from this company is exemplary. Thank you, Synapse, for giving me my life back. – Nicholas Essis

The NeuRx™ RA/4 is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day.