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Article History

Received: 15 September 2025

Accepted: 12 January 2026

First Online: 23 February 2026

Declarations

:

: Investigational device exemption (IDE) # G200013. ClinicalTrials.gov Identifier: NCT03596671.

: J.P.F.A.H., S.E.S., K.L.F., and R.R.D. reported being paid consultants for BlueWind Medical. The authors declare that these relationships have not influenced the design, conduct, or reporting of the study.An employee of BlueWind Medical authored the first draft of this manuscript to ensure protection of commercially valuable intellectual property; this first draft primarily consisted of summarizing the study methods and outcomes. The investigator authors listed above completed the results interpretation and conclusions to ensure that the appropriate scientific rigor was applied and relevant safety concerns were addressed. The investigator authors listed above were compensated for their participation in the study in that all study-related costs were covered by BlueWind Medical; but not for their time writing or reviewing the manuscript.

: The following lists all sites and details for Institutional Review Board (IRB) approval to participate in this study: