The FDA has given clearance to Synapse Biomedical, Inc. (Cleveland, Ohio) to market their NeuRx Diaphragm Pacing Stimulation system for people with spinal cord injury. The device, that is typically implanted through minimally invasive laparoscopic surgery, is indicated for patients with diaphragm dysfunction.
The new device, already approved in Europe last year, uses electrodes attached directly to the diaphragm to electrically stimulate its movement. The result is more natural breathing, and, hopefully, reduced potential to develop pulmonary complications.
From the press release:
In the clinical trial, NeuRx DPS™ provided 98% of SCI patients who had been dependent on
mechanical ventilation via a tracheostomy with an alternative that allowed them to breathe normally and live more active lives. To date, over 50% were able to be completely eliminate their need for mechanical ventilation.
Patients may be able to transfer from ventilator wards to home or assisted living, and even travel. Speech patterns, often laborious and strained in ventilatordependent patients, return to normal. The senses of taste and smell, severely diminished in ventilatordependent patients, return.
Controlled through a fourchannel battery powered external pulse generator, the NeuRx DPS™ eliminates the need for a source of electricity and the concern for power outages. Patients and caregivers are easily trained in the use of the NeuRx DPS™ reducing the need for external medical supervision. Elimination and reduction of the use of a mechanical ventilator also greatly reduces the patient’s risk of a serious complication: Ventilator Acquired Pneumonia (VAP). In a peer review 2007 report in Physical Medicine and Rehabilitation Clinical of North America by Stephen P. Burns MD, the incidence of SCI pneumonia for initial admitted patients was reported to be as high as 50 percent. The associated mortality from pneumonia was reported as 28% in the first year.
Company video explaining the workings of the system…
Press release: Synapse Biomedical Receives FDA Approval of NeuRx Diaphragm Pacing System (DPS)™ For Spinal Cord Injury Breathing Applications
Product page: NeuRx Diaphragm Pacing Stimulation (DPS)™ System …