Synapse Biomedical Inc. is touting an abstract regarding its eponymous Post Approval Study (PAS), a multi-center, clinical trial to further demonstrate the diaphragm pacing system’s safety and survival benefit. The paper has been accepted for presentation at the 26th International Symposium on ALS/MND.
Synapse’s NeuRx Diaphragm Pacing System® (NeuRx DPS®) is a four-channel, battery-powered neurostimulator with implanted electrodes. The device provides electrical stimulation to the muscle and nerves of the diaphragm, and is CE approved in Europe for treating patients with diaphragm dysfunction.
In the U.S.A, the system is FDA approval for ventilator dependency from spinal cord injury, providing ventilator support in patients with diaphragm dysfunction of neuromuscular origin. Diaphragm dysfunction can result in abnormal or absent respiration in patient populations of high-level spinal cord injury and other injuries or diseases affecting the neuromuscular respiratory pathways.
The Post Approval Study (PAS) of diaphragm pacing of ALS (Amyotrophic lateral sclerosis) patients, at 11 U.S. sites, with patient selection according to the FDA market-approved criteria, had finished enrollment of the required 60 patients in August 2014. In an interim analysis, patients in the PAS had 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 centers). The PAS interim analysis will be presented by Dr. Robert Miller, Principal Investigator of the study and Medical Director of the Forbes Norris ALS/MDA Research Center at CPMC in San Francisco.
“The PAS study supports our original IDE pivotal findings that DPS can extend patient survival. The IDE pivotal study, that the FDA reviewed to approve Diaphragm Pacing in the US for ALS patients, showed a median survival of 19.7 months from implant. We are confident in the safety and therapeutic utility of DPS when patients are carefully selected and screened according to proper criteria,” said Anthony Ignagni, President and Chief Executive Officer.
“We are committed to ongoing clinical research studies such as PAS and the NEALS randomized controlled trial to further clarify the safety and benefit of diaphragm pacing for people with ALS,” said Mike Fritz, VP Clinical and Regulatory Affairs.
Source: PR Newswire