Analysis of Diaphragm Pacing in 214 Patients with Lou Gehrig’s Disease (ALS) Shows Safety and Improved Survival Benefit
Synapse Biomedical Inc. announced today that an abstract regarding a decade of use of the NeuRx Diaphragm Pacing System® has been accepted for presentation at the 26th International Symposium on ALS/MND.
A DECADE OF DIAPHRAGM PACING FOR ALS/MND: OVERALL SURVIVAL AND CURRENT MANAGEMENT OF DIAPHRAGM PACING will be presented by Dr. Raymond Onders, Chair of Surgical Innovation at University Hospital Case Medical Center and Professor of Surgery at Case Western Reserve University School of Medicine at this year’s ALS/MND international program. “Diaphragm Pacing for ALS/MND patients has been analyzed and utilized safely in 214 patients over the past decade at University Hospitals of Cleveland.” said Dr. Onders. He went on to say, “Correct patient selection, neurophysiological testing, and surgical screening resulted in a median survival of 21.8 months post implantation.”
“Dr. Onders and his group have led the way in assessing and further refining the use of diaphragm pacing in ALS patients. We have seen his results exceeding the median survival of 19.7 months from implant in the IDE pivotal study (106 patients at 8 centers). In fact, 45% of the patients in the IDE pivotal study survived over two years and 20% survived over four years after implant. We are confident in the safety and therapeutic utility of NeuRx DPS® when patients are carefully selected and screened according to proper criteria.” said Anthony Ignagni, President and Chief Executive Officer.
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 ventilatory 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.
About Synapse Biomedical
Founded in 2002, Synapse Biomedical’s mission is to commercialize our life transforming neurostimulation platform used to treat people with respiratory insufficiency. Synapse is based in Oberlin, Ohio.