The Implantable System That Restores Hemodynamic Stability After Spinal Cord Injury
Phillips, A. A.; Gandhi, A. P.; Hankov, N.; Hernandez-Charpak, S. D.; Rimok, J.; Incognito, A.; Nijland, A. E. J.; D'Ercole, M.; Watrin, A.; Berney, M.; Damianaki, A.; Dumont, G.; Macellari, N.; De Herde, L.; Baaklini, E.; Smith, D.; Miller, R.; Lee, J.; Intering, N.; Ledoux, J.-B.; Ordonnez, J. G.; Newton, T.; Meliado, E. F.; Duguet, L.; Jacquet, C.; Bole-Feysot, L.; Rieger, M.; Gelenitis, K.; Dumeny, Y.; Caban, M.; Ganty, D.; Paoles, E.; Baumgartner, T.; Clinical Study Team, ; Onward Team, ; Harte, C.; Sasportes, C. D.; Romo, P.; Vouga, T.; Fasola, J.; Ravier, J.; Gautier, M.; Merlos, F.;
Show abstract
A spinal cord injury (SCI) causes immediate and sustained hemodynamic instability that threatens neurological recovery and impacts quality of life. Here, we establish the clinical burden of chronic hypotensive complications due to SCI in 1,479 participants, and expose the ineffective treatment of these complications with conservative measures. To address this clinical burden, we developed a purpose-built implantable system based on biomimetic epidural electrical stimulation (EES) of the spinal cord that immediately triggered robust pressor responses. The system durably reduced the severity of hypotensive complications in people with SCI, removed the necessity for conservative treatments, improved quality of life, and enabled engagement in activities of daily living. Central to the development of this therapy was the head-to-head demonstration in the same participants that EES must target the last three thoracic segments, and not the lumbosacral segments, to achieve the safe and effective regulation of blood pressure in people with SCI. These findings in 14 participants establish a path for a pivotal device trial that evaluates the safety and efficacy of EES to treat the underappreciated, treatment-resistant hypotensive complications due to SCI.
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