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Synapse Biomedical Receives FDA Humanitarian Use Device Designation for Amyotrophic Lateral Sclerosis (ALS)
Date:10/8/2010

Jacksonville, Fla.
  • California Pacific Medical Center, San Francisco, Calif.
  • Mount Sinai Medical Center, New York, N.Y.

  • The NeuRx DPS™ received CE Mark (CE Registration #518356) on November 20, 2007, as well as TGA approval in Australia on January 20th, 2009 and is approved for treating patients with diaphragm dysfunction in the European Union.  Several SCI patients have been implanted at prominent centers across Europe, Australia and the Middle East. ALS patients have been implanted successfully as well at leading centers, including Groupe Hospitalier Pitie-Salpetriere (Paris, France), Charite Universitatsmedizin Hospital (Berlin, GMBH), Royal Hallamshire Hospital (Sheffield, UK), University Medical Center (Groningen, Netherlands) and Landspitali - University Hospital (Reykjavik, Iceland).    

    The NeuRx DPS™ is currently approved in the United States under an HDE for spinal cord injury (SCI) patients, 18 years or older with stimulatable diaphragms but lack control of their diaphragms.  Today 34 centers in the United States are approved for SCI treatment and are listed at www.synapsebiomedical.com/products/us_sci.shtml

    Currently, the top three treatment centers worldwide are:

    • University Hospitals Case Medical Center, Cleveland, Ohio
    • Groupe Hospitalier Pitie-Salpetriere, Paris, France
    • Piedmont Hospital, Atlanta, Georgia

    Technical and Procedure Description

    The NeuRx DPS™ is a four-channel battery-powered external pulse generator (EPG) with electrodes that are implanted through minimally invasive laparoscopic surgery to provide electrical stimulation to the muscle and nerves of the diaphragm, the principal breathing muscle.  

    During the procedure, a surgeon creates four dime-size holes in the abdominal region and i
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    SOURCE Synapse Biomedical Inc.
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