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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).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"IRB approval and patient assent\/consent was obtained (1) in Japan at the clinical trial sites where tissue explants occurred. 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