Trial Information

Official Title: HDE Post-Approval Study (PAS) of NeuRx DPS for ALS

Summary

This post-approval study will follow 60 participants who have ALS, documented chronic hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants who are successfully implanted with the device will use it for daily diaphragm conditioning sessions. Participants will be followed for at least two years (until the last enrolled participant reaches the 2-year follow-up visit). Safety and probable benefit outcome measures will be assessed.

Phase: N/A

Sponsor: Synapse Biomedical

Overall Contacts:

Michael Fritz
888-767-3770 ext. 134
mfritz@synapsebiomedical.com