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Synapse Biomedical Receives FDA Approval for NeuRx Diaphragm Pacing System (DPS)® to Treat Amyotrophic Lateral Sclerosis (ALS)
Date:9/29/2011

CLEVELAND, Sept. 29, 2011 /PRNewswire/ -- Synapse Biomedical, Inc. announces that the U.S. Food and Drug Administration (FDA) has approved its NeuRx Diaphragm Pacing System (DPS)® for treating amyotrophic lateral sclerosis (ALS) patients who have stimulatable diaphragms and are experiencing chronic hypoventilation.  

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(Fact sheets, patient testimonials, product videos and images: www.synapsebiomedical.com/news/media)

The FDA Humanitarian Device Exemption (HDE) marketing approval is based on demonstration that NeuRx DPS® could help ALS patients live longer and sleep better than the current standard of care, alone. These findings are the result of a multicenter clinical trial that enrolled 106 patients and treated 86 for chronic hypoventilation at:

  1. University Hospitals Case Medical Center, Cleveland, Ohio
  2. Johns Hopkins, Baltimore, Md.
  3. Stanford University, Stanford, Calif.
  4. Methodist Neurological Institute, Houston, Texas
  5. Henry Ford Health System, Detroit, Mich.
  6. Mayo Clinic, Jacksonville, Fla.
  7. California Pacific Medical Center, San Francisco, Calif.
  8. Groupe Hospitalier Pitie-Salpetriere, Paris, France

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

Amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Geh
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SOURCE Synapse Biomedical Inc.
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