CLEVELAND, Oct. 8 /PRNewswire/ — Synapse
Biomedical Inc. announces today that they have received the
U.S. Food and Drug Administration (FDA) designation of the NeuRx
Diaphragm Pacing System (DPS)™ as a Humanitarian Use
Device (HUD) for amyotrophic lateral sclerosis (ALS)
patients with a stimulatable diaphragm who are experiencing chronic
hypoventilation and has now submitted for Humanitarian Device
Exemption (HDE) approval.
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The HUD designation establishes that the NeuRx DPS™ is a
medical device intended to benefit patients in the treatment or
diagnosis of a disease or condition that affects or is manifested
in fewer than 4,000 individuals in the United States per
year. The HUD designation is necessary to apply for HDE
market approval. With our submission of the HDE application
on October 8, 2010, the FDA will now review the Synapse HDE
application to determine whether NeuRx DPS™ is safe and has
probable benefit for ALS patients who meet the HUD population
criteria. “We anticipate that the HDE initial review will
take 75 days although FDA questions can result in additional review
cycles,” stated Mike Fritz, Synapse VP Clinical & Regulatory
Affairs.
Amyotrophic lateral sclerosis (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. Voluntary muscle control is lost as the
nerves die. As a result, patients lose the ability to breathe,
without ventilator support, as the phrenic nerve to their diaphragm
muscles fail. Approximately 30
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