Interim results reported for NeuRx Diaphragm Pacing System in diaphragm dysfunction- Synapse Biomedical

Synapse Biomedical reported that the US multi-centre, Post Approval Study (PAS) studying the use of the NeuRx Diaphragm Pacing System (DPS) in Amyotrophic Lateral Sclerosis is continuing to enrol patients, and that interim results have been reported. The Post Approval Study (PAS) is being conducted at 11 sites in the United States and patient selection is according to the FDA market-approved criteria. The PAS study group met their initial enrolment goal ahead of schedule in August 2014. The study has since expanded the enrolment target to 150 participants.

An interim analysis of the current data (n=60 patients) on the use of NeuRx Diaphragm Pacing System (DPS) revealed no significant safety issue. The interim analysis also showed a median survival of 20.9 months post-implant. These results are consistent with the survival demonstrated in the original IDE pivotal study (106 patients; 8 centres) which reported a median survival of 19.7 months after implant. Data will be presented at the 26th International Symposium on ALS/MND.