A Breath of Fresh Air

The diaphragm-pacing system implanted in Christopher Reeve last month by surgeons at University Hospitals of Cleveland [see article, p2] represents a victory for neurotechnology in many respects. To begin with, it is the first real-life endorsement of neural prostheses and functional electrical stimulation by the prominent actor and disabilities activist. While Reeve made a public endorsement of FES as part of his exercise regimen last year, stimulation seemed to be relegated to a conditioning role, as opposed to a functional role, which is the case with the FES breathing system

The procedure also delivered a much needed shot of publicity and media awareness to this application. Case Western Reserve University emeritus professor J. Thomas Mortimer, whose Applied Neural Control Lab developed the system, has been laboring in the dark for many years with this device.

Also, the device represents an almost textbook example of how FES systems can be readily cost-justified compared to current therapies and treatments. Reeve’s comments on that subject are worth quoting: “The constant and high cost of care for ventilator-dependent patients not only exhausts most insurance policies but contributes to strain on families and caregivers. Once this procedure receives FDA approval, these patients and their caregivers should be able to achieve significant improvements in their quality of life.”

Nonetheless, the procedure points up at least one frustrating difficulty that continues to hound neural engineers in this field and that is the inherent unmarketability of an FES breathing system resulting from the relatively small market of potential users. Of the 10,000 new cases of spinal cord injury each year in the U.S., only about 1,000 patients require mechanical ventilation for some period after injury. Of these, there are perhaps 300 cases per year that might benefit from life-long breathing support provided by the implanted device. This patient population is even smaller than the universe of C5/C6 quadriplegics that NeuroControl Corp. was targeting with its FreeHand device until it stopped marketing the product last year.

Clearly, it is going to be a difficult proposition indeed to convince a neurotechnology firm that there is sufficient profit here to market the device. What’s desperately needed is a way of pricing a product in a way that enables a manufacturer to recover research, development, and marketing costs and compensate for the relatively small number of units manufactured. Manufacturers in the defense industry have accomplished exactly this feat. With appropriate help from the U.S. government, and public understanding of the overall benefit to society, the neurotechnology industry could do the same.

James Cavuoto
Editor and Publisher