Diaphragm Pacing System Aids Spinal Cord Injury Victims Breathe

When stimulated by the device, the diaphragm contracts, mimicking natural breathing, and allows air to fill the upper and lower parts of the lungs rather than forcing air in with a mechanical ventilator. The system is controlled through a four-channel battery-powered external pulse generator, which 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 risk of ventilator-acquired pneumonia (VAP), a serious complication of mechanical ventilation. Additionally, patients may be able to transfer from ventilator wards to home or assisted living, and even travel. Speech patterns, often laborious and strained in ventilator-dependent patients, return to normal. The senses of taste and smell, severely diminished in ventilator-dependent patients, also return.

The device is implanted using a form of minimally invasive laparoscopic surgery via four small incisions in the abdominal region; a laparoscope is inserted so that the diaphragm muscle can be seen. The surgeon then places the electrodes in the diaphragm. The surgery is done on an outpatient basis, with a short rehabilitation period. The patient then has the device programmed to allow an effective and comfortable breath. Because of the patient's injury, the diaphragm is weak and the patient must condition and strengthen the diaphragm to allow increasing amount of time off the ventilator. Over time, many patients are able to free themselves completely from ventilator use. The NeuRx DPS is a product of Synapse Biomedical (Oberlin, OH, USA), and has been approved by both the European Community (CE Marking) and the U.S. Food and Drug Administration (FDA).

"We are pleased the FDA has given approval to NeuRx DPS so we can now offer individuals throughout the United States the ability to breathe on their own once again,” said Anthony R. Ignagni, Synapse president and CEO. "The national launch of the NeuRx DPS represents Synapse's first step in applying its NeuRx neurostimulation platform to U.S. patients with chronic and acute respiratory insufficiency which has the promise of reducing healthcare costs while improving outcomes.”

Trials for use of the NeuRx DPS in treating amyotrophic lateral sclerosis (ALS) patients are also underway. ALS, commonly referred to as Lou Gehrig's disease, is a rapidly progressing, incurable, and fatal neuromuscular disease characterized by progressive muscle weakness that results in paralysis. All voluntary control muscles are weakened, and, as a result, diaphragm muscles fail. Patients lose the ability to breathe without ventilator support. Approximately 30,000 people in the U.S. live with ALS, and over 5,000 new cases are diagnosed each year.


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Synapse Biomedical