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Diaphragm pacing system receives FDA approval for use with ALS patients
Date:9/29/2011

Exemption based on demonstration that NeuRx DPS could help ALS patients live longer, have better quality of life and sleep better than the current standard of care alone. These findings are the result of a multi-center clinical trial that enrolled 144 patients and treated 88 for chronic hypoventilation at UH Case Medical Center, Johns Hopkins, Stanford University and other major medical centers in the United States and France.

ALS is a rapidly progressing, incurable and fatal neuromuscular disease. As the phrenic nerve to the diaphragm muscles fails, patients have difficulty breathing. About 30,000 people in the United States live with ALS. More than 5,600 new cases are diagnosed each year, with an estimated subset of 3,300 with both chronic hypoventilation and intact phrenic nerves that could benefit from the NeuRx DPS treatment.

In ALS, NeuRx DPS is implanted through minimally invasive laparoscopic surgery and provides electrical stimulation to the diaphragm muscles. Repeated use of DPS conditions the diaphragm muscles, delaying respiratory failure and the need for tracheostomy and mechanical ventilation.


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Contact: George Stamatis
george.stamatis@uhhospitals.org
216-844-3667
University Hospitals Case Medical Center
Source:Eurekalert

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