Users of NeuRx Diaphragmatic Pacing System™ Report High Satisfaction and Improved Medical Outcomes

ATLANTA – A study of a relatively new diaphragmatic pacing system for people with spinal cord injury who are ventilator-dependent shows high patient satisfaction and improved medical outcomes, according to research that Shepherd Center respiratory medicine professionals will present on Dec. 8 at the International Respiratory Congress meeting in Las Vegas.

The diaphragmatic pacer, called the NeuRx Diaphragmatic Pacing System (DPS)TM, is intended for use in people with stable, high-level spinal cord injuries whose diaphragms are able to be stimulated, but lack voluntary diaphragmatic control. It allows people to breathe without the assistance of a mechanical ventilator for at least four consecutive hours a day. Doctors implant the device using standard laparoscopic surgical techniques during an outpatient procedure. By providing repetitive electrical stimulation to implanted electrodes, the patient’s diaphragm contracts, allowing the patient to breathe.

“The device can make a significant and dramatic change in people’s lives,” said Andrew Zadoff, M.D., medical director of the intensive care unit and pulmonary services at Shepherd Center. “People who are successful in using it have made a commitment to weaning from the ventilator, which is hard work. But they want to improve their quality of life.”

Following clinical trials of NeuRx DPSTM in patients at Shepherd Center and elsewhere, the FDA approved the use of the device in June 2008. Since then, 16 Shepherd Center spinal cord injury (SCI) patients have had the device implanted, and 128 other people with SCI have undergone the procedure worldwide. To evaluate the patients’ success in using NeuRx DPS TM, Shepherd Center clinical improvement advisor Adrienne Cunningham, RRT, MPH, interviewed 11 of the Shepherd patients for the study. She and Dr. Zadoff will present the research at the International Respiratory Congress meeting. 

Surveyed participants reported on the amount of time they use the NeuRx DPSTM, the amount of time they use a mechanical ventilator, family support, reasons for continuing to use a mechanical ventilator, and overall satisfaction for the NeuRx DPS TM.

All participants could sustain the need for mechanical ventilation for at least 12 hours a day. One participant was able to surpass mechanical ventilation for 13 consecutive hours a day without the need for the NeuRx DPSTM. Seven of the 11 study participants returned to mechanical ventilation at night because of light respiratory distress and/or comfort. Three patients reported using the device 24 hours a day without any need for the mechanical ventilator. All participants reported having good family support and overall satisfaction for using the device. One participant had an arrhythmia associated with the device. Subsequently, the lead closest to the pericardium was turned off, and no other complications have been reported.

The NeuRx DPS TM was developed by researchers at Case Western Reserve University and is licensed by Synapse Biomedical Inc.

Inpatients who are interested in the NeuRx DPSTM can initiate the required screening process by simply asking their doctor. Outpatients are asked to contact Shepherd Center case manager Brenna Blocker at 404-367-1253 or brenna_blocker@shepherd.org. More information is available at www.shepherd.org/dps.