The implantable system that restores hemodynamic stability after spinal cord injury (2024)

Competing Interest Statement

The authors declare competing financial interests: G.C., A.Phillips., J.W.S, J.Bloch., R.D., L.Asboth, T.M. and A.R. hold various patents in relation with the present work. G.C., A.Philips., J.Bloch, V.D., J.Murphy and H.L. are minority shareholders of ONWARD medical, a company with direct relationships with the presented work. G.C., J.Bloch., A.Phillips. and R.D. are consultants of ONWARD medical. P.B., M.D., L.D., K.G., C.J., H.L., C.Picq, M.Rieger, E.R., R.V., A.W., F.A., S.Morand, J.Pradarelli, E.Paoles, J.Murphy, Y.D., M.C. D.G., A.K, J.D., F.S. and V.D. are employees of ONWARD medical. N.Kuster and E.N. are shareholders of ZMT Zurich MedTech AG, which produces the Sim4Life software. The other authors declare no competing interests.

Clinical Trial

NCT04994886 NCT05044923 NCT05111093 NCT05941819

Funding Statement

This work was financially supported by: Eurostars project E!113969 PREP2GO, DARPA subaward A21-0795-S001 (P.O. 1083297), Eurostars E!1748 IMPULSE, Medtronic (ERP-2020-12543), Onward Medical, PHRT-279, the Defitech foundation, CIHR, Cumming Medical Research Fund, Edith Rodie Estate, Hotchkiss Brain Institute, Libin Cardiovascular Institute.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Swissethics gave ethical approval for this work (Ethics reference number: CER-VD 2021-00588). Swissmedic gave regulatory approval before the start of the study for the STIMO-HEMO trial conducted in Switzerland (Competent authorities number: Swissmedic 10000882). The STIMO-HEMO study followed the Declaration of Helsinki (clinicaltrials.gov ID: NCT 04994886).The Canadian ethical authorities gave ethical approval for this work (Ethics reference number: REB21-0027). The HEMO trial was conducted following the Declaration of Helsinki in Canada (clinicaltrials.gov ID: NCT 05044923).Swissethics gave ethical approval for this work (Ethics reference number: CER-VD 2021-D0025). Swissmedic gave regulatory approval before the start of the study for the HemON trial conducted in Switzerland (Competent authorities number: Swissmedic 10000932). The HemON study followed the Declaration of Helsinki (clinicaltrials.gov ID: NCT 05111093).The Central Committee on Research Involving Human Subjects of Radboud University Medical Center gave ethical approval for this work (Ethics reference number: 2023-16316). The Central Committee on Research Involving Human Subjects gave regulatory approval before the start of the study for the HemON-NL trial conducted in The Netherlands (CCMO NL83694.000.23). The HemON-NL study followed the Declaration of Helsinki (clinicaltrials.gov ID: NCT 05941819).Veritas Independent Review Board, the Research Ethics Board of Universite Laval (principal investigators institution) and local research ethics IRBs across Canada gave ethical approval for the epidemiological survey in this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes