Intramuscular Diaphragm Stimulation (NeuRx DPS RA/4 Respiratory Stimulation System) for Respiratory Insufficiency or Failure

February 23, 2015 | Emerging Technology Reports


This Emerging Technology Report provides an analysis of full published studies in the clinical literature through January 23, 2013. We updated the literature search for a Hotline Response by searching PubMed, the Cochrane Library, and selected web-based resources for relevant documents published from January 1, 2009, through April 28, 2014. Those searches identified two additional case series1,2 that report on patients with amyotrophic lateral sclerosis (ALS) who had diaphragm pacing. One case series1 of 10 patients with ALS reported that 2 patients developed perioperative deep vein thrombosis. The other case series2 reported final results of the pilot study of diaphragm pacing in patients with ALS. The findings of these publications do not change the conclusions in this report.

Proprietary names: NeuRx® DPS RA/4 Respiratory Stimulation System, NeuRx Clinical Station, PermaLoc® electrodes

Generic names: breathing pacemaker, diaphragm pacing, direct diaphragm stimulation, electrophrenic respiration, laparoscopic diaphragm pacing, phrenic nerve pacing via intramuscular diaphragm electrodes, ventilator weaning

Note: Surgeons implanted this device into actor Christopher Reeve in 2003; surgeons often refer to the procedure as "Christopher Reeve Surgery."

Respiratory insufficiency or failure may result from a spinal cord injury (SCI) or neurologic disease (i.e., amyotrophic lateral sclerosis ALS).3 This report focuses on the NeuRx DPS RA/4 Respiratory Stimulation System (Synapse Biomedical, Inc.) for use in patients with either SCI or ALS.

SCI occurs when trauma or disease damages the spinal cord, resulting in partial or complete paralysis,4,5 and the degree of paralysis relates to the cervical level and severity of injury. Cervical (neck) injuries may result in four-limb paralysis, a condition referred to as tetraplegia.5 Injuries at or above the C-3 spine level (i.e., high tetraplegia) have a greater impact on respiratory function than injuries below the C-3 level.4

The most common causes of high tetraplegia are motor vehicle accidents, falls, violence, and sports injuries.6 Risk factors for SCI include being male and/or African-American, using drugs or alcohol while driving, and being age 45 years or older.5,6 Life expectancy after a high cervical SCI is reduced by 40% to 70% depending on age at the time of the injury.7 The leading causes of early death in...

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