Synapse Biomedical Inc., a company that commercializes the NeuRx Diaphragm Pacing System (DPS), has recently announced it will be presenting data on the company’s Post Approval Study (PAS), a multi-center trial that demonstrated DPS’s safety and survival benefit, during the 26th International Symposium on ALS/MND. Data 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.
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Motor neurons reach from the brain to the spinal cord and from this structure to the muscles throughout the body. The progressive degeneration of motor neurons in ALS eventually leads to their death, affecting the brain’s ability to initiate and control muscle movement. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed.
The NeuRx Diaphragm Pacing System (DPS) consists of four electrodes implanted in the diaphragm that stimulate the muscle, a fifth electrode under the skin to complete the electrical circuit, a connector holder, a cable and an external battery powered pulse generator, which provides the timing and stimulus control, regulating diaphragm muscle movement and affecting respiration.
The PAS clinical trial was conducted across 11 sites in the United States. Patient selection was conducted according to the U.S. Food and Drug Administration (FDA) market-approved criteria, with a total of 60 patients enrolling in the study.
The results showed that post-implant ALS patients had a median survival of 20.9 months, which is consistent with the survival rates observed in the original IDE pivotal study that included 106 patients in 8 clinical centers.
“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 in a news release Anthony Ignagni, Synapse Biomedical 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,” added Mike Fritz, VP Clinical and Regulatory Affairs.