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Authors
Bai, Rong https://orcid.org/0000-0002-3106-7318
Liao, Yu
Wang, Xunzhang
Rosenthal, Kevin
Vessey, Justin
Mazor, Meital
Su, Wilber https://orcid.org/0000-0002-0639-6822
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Article History
Received: 11 March 2024
Accepted: 23 May 2024
First Online: 3 June 2024
Declarations
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: The histopathologic study performed by Horus Scientific (HS) was conducted in compliance with the United States Food and Drug Administration (FDA) Good Laboratory Practice (GLP) regulations, standards, and guidelines set forth in Title 21 of the Code of Federal Regulations (CFR) Part 58, except that Microsoft® Excel, a non-validated computer program, was used to capture histopathologic data and perform data calculations.The Synaptic Nordica Cryoablation System is currently being studied under the SENSATION IDE clinical study (NCT05905835): “Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation with the Synaptic Compliant Cryoablation Balloon and System.”The study protocol was reviewed and approved by the T3 Labs Institutional Animal Care and Use Committee (IACUC) and by Designated Member Review (Study Code: SB01D).
: Dr. Wilber Su and Dr. Xunzhang Wang received compensation as consultants of Synaptic Medical.
