Synapse Biomedical Inc. announced today that an abstract regarding Synapse Biomedical’s Post Approval Study (PAS), a multi-center, clinical trial to further demonstrate the diaphragm pacing system’s safety and survival benefit has been accepted for presentation at the 26th International Symposium on ALS/MND.
The Post Approval Study (PAS) of diaphragm pacing of ALS 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, Principle 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.
About NeuRx DPS® Technology
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.
The NeuRx DPS® received CE Marking (CE Registration #518356) on November 20, 2007 and is approved for treating patients with diaphragm dysfunction in the European Union.
The NeuRx DPS® received FDA approval for ventilator dependency from spinal cord injury on June 17, 2008. In Spinal Cord Injury (SCI), the NeuRx DPS® provides 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 NeuRx DPS® received FDA approval for treating chronic hypoventilation from ALS on September 28, 2011. The NeuRx DPS® has demonstrated that it can help people with ALS live longer and sleep better than the current standard of care, alone.