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Article History

Received: 17 December 2021

Revised: 20 April 2022

Accepted: 16 May 2022

First Online: 13 June 2022

Declarations

:

: The authors declare that they have no conflict of interest.

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments. The explant study was approved by the Institutional Review Board (IRB) of the Medical College of Wisconsin (HRRC 239-03). The explant site had no contact with the patients in Japan. IRB approval and patient assent/consent was obtained in Japan at the clinical trial sites (both Kobe Medical Center and Ichinomiya Nishi Hospital) where tissue explants occurred during the PMDA clinical trial sponsored by Medtronic (MDT-4113).

: IRB approval and patient assent/consent was obtained (1) in Japan at the clinical trial sites where tissue explants occurred. IRB approval was also obtained (2) in USA at the histological analysis site (MCW HRRC 239-03) where analyses occurred.

: The device is now FDA approved for the indicated usage in the United States but was also approved for the indicated usage outside the United States. The device that is the subject of this manuscript was being evaluated as part of a Japanese PMDA-approved investigational device exemption protocol in Japan.