Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

State-of-the-art preclinical testing of the OMEGATM left atrial appendage occluder

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Impact of early hospital discharge on clinical outcomes after transcatheter aortic valve implantation

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Spontaneous thrombosis of a transcatheter aortic valve replacement-induced aortic root pseudoaneurysm

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Feasibility and safety of a fully percutaneous transcatheter aortic valve replacement program

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. First-in-human results of the OMEGA™ Left Atrial Appendage Occluder for Patients with Non-Valvular Atrial Fibrillation

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Impact of early hospital discharge on clinical outcomes after transcatheter aortic valve implantation

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Contemporary management of severe symptomatic bicuspid aortic valve stenosis: the BiTri Registry

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Vis graf over relationer

OBJECTIVES: This study aimed to present a new approach of thorough preclinical testing of a novel left atrial appendage (LAA) occluder device.

BACKGROUND: The development of a safe and effective LAA occluder has been shown to be challenging.

METHODS: The novel OMEGATM LAA occluder (Eclipse Medical, Ireland) was tested in a porcine model and three-dimensional (3D) human LAA models - this as a prelude to its first-in-human use.

RESULTS: In a first series of in-vivo 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-vivo experiments. The second generation OMEGATM device was designed with thinner wires, leading to a profile reduction. Based on in-vitro testing of different OMEGATM device sizes implanted at different depths in human three-dimensional (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-retaining inverted cup should have 10%-25% 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-vivo and in-vitro testing resulted in an optimized pre-procedural planning of the first-in-human case treated with the OMEGATM device.

CONCLUSIONS: This series of carefully planned in-vivo and in-vitro 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-in-human cases and may become the standard approach for device development and preclinical testing in the future.

OriginalsprogEngelsk
TidsskriftCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Vol/bind97
Udgave nummer7
Sider (fra-til)E1011-E1018
ISSN1522-1946
DOI
StatusUdgivet - 1 jun. 2021

Bibliografisk note

© 2020 Wiley Periodicals LLC.

ID: 62239925