The FDA has approved Synapse Biomedical’s NeuRx Diaphragm Pacing System for treating amyotrophic lateral sclerosis (ALS) patients who have stimulatable diaphragms and are experiencing chronic hypoventilation.
The FDA Humanitarian Device Exemption marketing approval is based on demonstration that NeuRx DPS ould 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 8 sites.
Synapse Biomedical was founded in Cleveland in 2002.
“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 Synapse Biomedical President and CEO Anthony Ignagni.
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. As the phrenic nerve to the diaphragm muscles fails, patients lose the ability to breathe without ventilator support. Approximately 30,000 people in the U.S. live with ALS. More than 5,600 new cases are diagnosed each year.
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