Synapse Biomedical has paradigm changing neurostimulation products for respiratory insufficiency disorders. Synapse management is executing a growth strategy which combines their proprietary platform technology, industry knowledge and opinion leading relationships to address multiple clinical conditions, including spinal cord injury (SCI), amyotrophic lateral sclerosis (ALS), critical care, and sleep disorders.
There exists growing clinician recognition that current ventilation methods cause atrophy and accelerate respiratory compromise. The Diaphragm Pacer, with its minimally invasive approach, is both scientifically and clinically proven to preserve muscle strength and maintain vital capacity.
Decreased Regulatory Risk: CE Mark obtained for broad approval for European markets. U.S. approval for spinal cord injury indication obtained. Canadian, Australian, and Israeli approvals are in process. Multi center clinical data has been collected on over 125 implanted patients at a dozen institutions. This data has successfully demonstrated the safety of the intervention with the study of benefit for US approval in ALS nearing completion.
DESCRIPTION OF INITIAL APPLICATIONS
An estimated 6,000 U.S. ventilator dependant SCI patients spend over $100,000/year on ventilatory support and still their life expectancy is reduced by 40 – 70%. To date, the Diaphragm Pacer has been implemented in over 50 SCI patients worldwide with long term beneficial results, freeing 98% of patients from mechanical ventilation.
Barcelona JIVD Onders (PDF)
Onders 2008 Worldwide DPS Use (PDF)
ALS and Diaphragm Pacing Surgery (PDF)
Raymond Onders CV (PDF)