Synapse Biomedical Inc. (www.synapsebiomedical.com) announced today it has completed the enrollment of the post-approval study of its NeuRx DPS® System for ALS patients. The last patient needed to meet the FDA enrollment requirement was implanted over a month and a half ahead of schedule. The NeuRx DPS®, which is the only medical device approved by the FDA specifically for ALS patients, is a humanitarian device that obtained approval at the end of 2011 with the demonstration of safety and probable benefit. This post-approval study, validating the safety, is also intended to help identify the patient population that may benefit most from this therapy.
"When we see the impact that this device can have for individual patients, we know that providing this supporting therapy is meaningful for ALS patients", said Anthony Ignagni, President and Chief Executive Officer. "Our FDA approval demonstrated the safety of the device and provided evidence of improvements in survival and sleep for these patients. It is our mission to make the NeuRx DPS available for the people with this devastating disease and to continue to advance the knowledge base of how and who to best use it in." The technology originated at Case Western Reserve University and University Hospitals Case Medical Center(UHCMC) for spinal cord injured patients and was developed further by Synapse for ALS patients following the many inquiries from patients.
Raymond Onders, M.D., Chair of Surgical Innovation at UHCMC and Co-founder of Synapse Biomedical, Inc, recently published the final pilot results of DPS in ALS states, "DPS has a proven safe role in maintaining respiration in ALS patients with one of our initial pilot patients using DPS for 6 years without the need for invasive ventilation."
Robert Miller, M.D., Lead Principal Investigator with the Forbes Norris ALS Clinic at California Pacific Medical Center, said, "We are proud to have helped complete enrollment ahead of schedule for the Post Approval Study of the NeuRx Diaphragm Pacing System. The DPS is a novel therapeutic option for those diagnosed with ALS and we hope the PAS trial will help clarify its benefits."
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