Synapse Biomedical Wins New Approval for Diaphragm Pacing System to Free Patients from Ventilators
Ruling will make device more affordable and accessible for those with spinal cord injuries.
Ruling will make device more affordable and accessible for those with spinal cord injuries.
Kimberley R. Monden PhD, Jennifer Coker MPH, Susan Charlifue PhD, Stephanie J. Bennett BS, Christina Draganich DO, David Coons MD, Jeffrey Berliner DO. Abstract Background: Participants completed self-report questionnaires focused on their DPS usage and mechanical ventilation, as well as their experiences and satisfaction with the DPS.
Kerwin AJ, Zuniga YD, Yorkgitis BK, Mull J, Hsu AT, Madbak FG, Ebler DJ, Skarupa DJ, Shiber JR, Crandall ML. Abstract Background: The DPS implantation in acute CSCI patients produces significant improvements in spontaneous Vt and reduces time to liberation from mechanical ventilation.
Kerwin AJ, Diaz Zuniga Y, Yorkgitis BK, Mull J, Hsu AT, Madbak FG, Ebler DJ, Skarupa DJ, Shiber J, Crandall ML. Abstract Background: Cervical spinal cord injury (CSCI) is devastating and costly. Previous research has demonstrated that diaphragm pacing (DPS) is safe and improves respiratory mechanics. This may decrease hospital stays, vent days, and costs. We hypothesized DPS implantation would facilitate liberation from ventilation and would impact hospital charges.
Matthew R. Kaufman, Thomas Bauer, Stuart Campbell, Kristie Rossi, Andrew Elkwood & Reza Jarrahy. Abstract Background: Chronic ventilator dependency in cervical tetraplegia is associated with substantial morbidity. When non-invasive weaning methods have failed the primary surgical treatment is diaphragm pacing.
Kerwin AJ, Yorkgitis BK, Ebler DJ, Madbak FG, Hsu AT, Crandall ML. Abstract Background: Cervical spinal cord injury (CSCI) is devastating. Respiratory failure, ventilator-associated pneumonia (VAP), sepsis, and death frequently occur. Case reports of diaphragm pacing system (DPS) have suggested earlier liberation from mechanical ventilation in acute CSCI patients. We hypothesized DPS implantation would decrease VAP and facilitate liberation from ventilation.
Onders RP, Elmo M, Kaplan C, Schilz R, Katirji B, and Tinkoff G. Abstract Background: Cervical spinal cord injury can result in catastrophic respiratory failure requiring mechanical ventilation with high morbidity, mortality, and cost. Diaphragm pacing was developed to replace/decrease mechanical ventilation. We report the largest long-term results in traumatic cervical spinal cord injury.
Dean, J.M., Onders, R.P. & Elmo, M.J. Abstract Background: Pediatric spinal cord injury (SCI) at C3 level and above results in tetraplegia and profound respiratory insufficiency requiring long-term positive pressure ventilation (PPV) and is associated with significant complications and morbidity. Diaphragm pacing (DP), a form of functional electrical stimulation (FES) of the diaphragm, provides natural negative pressure breathing which can replace or decrease PPV need. There are numerous reported benefits of DP including improved speech, reduced caregiver burden, and decrease in secretions.
Garara B, Wood A, Marcus HJ, Tsang K, Wilson MH, and Khan M. Abstract Background: Intramuscular diaphragmatic stimulation using an abdominal laparoscopic approach has been proposed as a safer alternative to traditional phrenic nerve stimulation. It has also been suggested that early implementation of diaphragmatic pacing may prevent diaphragm atrophy and lead to earlier ventilator independence.
Kaufman, M.R., et al., Abstract Background: Patients who are ventilator dependent as a result of combined cervical spinal cord injury and phrenic nerve lesions are generally considered to be unsuitable candidates for diaphragmatic pacing due to loss of phrenic nerve integrity and denervation of the diaphragm.
Posluszny JA, Jr., Onders R, Kerwin AJ, Weinstein MS, Stein DM, Knight J, Lottenberg L, Cheatham ML, Khansarinia S, Dayal S, Byers PM and Diebel L. Abstract Background: Ventilator-dependent spinal cord-injured (SCI) patients require significant resources related to ventilator dependence. Diaphragm pacing (DP) has been shown to successfully replace mechanical ventilators for chronic ventilator-dependent tetraplegics. Early use of DP following SCI has not been described. Here, we report our multicenter review experience with the use of DP in the initial hospitalization after SCI.
Onders, R.P., et al., Background Abstract: Diaphragm pacing (DP) can replace mechanical ventilation in tetraplegics and in trials has assisted respiration in amyotrophic lateral sclerosis patients. This report describes the results of DP in patients with cardiac pacemakers.
Onders RP, Ponsky TA, Elmo M, Lidsky K, Barksdale E. Background Abstract: Diaphragm pacing (DP) has been shown to successfully replace mechanical ventilators for adult tetraplegic patients with chronic respiratory insufficiency. This is the first report of DP in ventilator-dependent children.
Onders, R.P., et al., Abstract Background: Patients with high spinal cord injury(SCI) face death or life with mechanical ventilation. Ventilators, although life-saving, are inconvenient and associated with significant risks. This report outlines a single institution experience with the diaphragm pacing stimulation (DPS) system since the first implantation 7 years ago.