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

An electronic system that stimulates the nerve of the diaphragm muscles has received approval from the Food and Drug Administration (FDA) for use in patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease. The system called NeuRx Diaphragm Pacing System (DPS) will help ALS patients breathe longer without the aid of a ventilator.

Dr. Raymond Onders, the surgeon at University Hospitals (UH) Case Medical Center who helped develop and test DPS and who lost his own sister to ALS this past year, began testing DPS 15 years ago on spinal cord injured patients such as the late actor Christopher Reeve. In 2004, this research expanded to included patients with ALS patients whose progressive muscle weakness leads to an inability to breathe without ventilator support.

"I lost my sister to this devastating disease during the FDA approval process," said Dr. Onders. "I also have seen the significant benefit diaphragm pacing can provide to patients. Diaphragm pacing has improved the breathing and quality of life of many of the patients I have treated. I am committed to searching for the cure for this disease but until then and with this approval we are now able to continue helping ALS patients until that cure is found," said Dr. Onders who is Director of Adult Minimally Invasive Surgery at UH Case Medical Center and who holds the Margaret and Walter Remen Chair in Surgical Innovation and is Professor of Surgery at Case Western Reserve University School of Medicine.

NeuRx DPS is made by Synapse Biomedical, Inc., a company co-founded by Dr. Onders.

Anthony R. Ignagni, Synapse's President and Chief Executive Officer, said, "We are very pleased the FDA approved this next indication for use of the NeuRx DPS to treat chronic hypoventation in ALS. In granting approval, it allows us to now offer individuals with ALS more time to be able to breathe with their own muscles."

The FDA granted a Humanitarian Device
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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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