{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,13]],"date-time":"2025-05-13T14:40:13Z","timestamp":1747147213274,"version":"3.40.5"},"reference-count":19,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,10,9]],"date-time":"2020-10-09T00:00:00Z","timestamp":1602201600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>This study aimed to present a new approach of thorough preclinical testing of a novel left atrial appendage (LAA) occluder device.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The development of a safe and effective LAA occluder has been shown to be challenging.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The novel OMEGATM LAA occluder (Eclipse Medical, Ireland) was tested in a porcine model and three\u2010dimensional (3D) human LAA models \u2013 this as a prelude to its first\u2010in\u2010human use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In a first series of in\u2010vivo experiments, the OMEGATM LAA occluder was shown to have a satisfactory device biocompatibility in a porcine model. The design of the OMEGATM device was further refined and optimized following three more series of in\u2010vivo experiments. The second generation OMEGATM device was designed with thinner wires, leading to a profile reduction. Based on in\u2010vitro testing of different OMEGATM device sizes implanted at different depths in human three\u2010dimensional (3D) LAA models, it could be determined that (1) the landing zone should be measured at a median depth of 12 mm from the LAA ostium; (2) the distal self\u2010retaining inverted cup should have 10%\u201025% compression to minimize device embolization risk; and (3) the disc should be slightly inverted, i.e. pulled into the LAA, to promote complete LAA occlusion. The combined in\u2010vivo and in\u2010vitro testing resulted in an optimized pre\u2010procedural planning of the first\u2010in\u2010human case treated with the OMEGATM device.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This series of carefully planned in\u2010vivo and in\u2010vitro experiments allowed demonstration of the safety and efficacy of the OMEGATM LAA occluder. This approach of thorough preclinical testing of medical devices may reduce the risk of complications in first\u2010in\u2010human cases and may become the standard approach for device development and preclinical testing in the future.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.29331","type":"journal-article","created":{"date-parts":[[2020,10,9]],"date-time":"2020-10-09T12:44:41Z","timestamp":1602247481000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["State\u2010of\u2010the\u2010art preclinical testing of the OMEGA<sup>TM<\/sup> left atrial appendage occluder"],"prefix":"10.1002","volume":"97","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9674-0278","authenticated-orcid":false,"given":"Ole","family":"De Backer","sequence":"first","affiliation":[{"name":"Department of Cardiology, Rigshospitalet Copenhagen University Hospital  Copenhagen 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