Synapse Biomedical Receives FDA Humanitarian Use Device Designation for Amyotrophic Lateral Sclerosis (ALS)
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.
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