Research
Print page Print page
Switch language
Rigshospitalet - a part of Copenhagen University Hospital
Published

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

Research output: Contribution to journalJournal articleResearchpeer-review

DOI

  1. Atrial fibrillation after closure of patent foramen ovale in the REDUCE clinical study

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Clinical evaluation of the Hydra self-expanding transcatheter aortic valve: 6 month results from the GENESIS trial

    Research output: Contribution to journalJournal articleResearchpeer-review

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

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Microcirculatory Function in Nonhypertrophic and Hypertrophic Myocardium in Patients With Aortic Valve Stenosis

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Computed Tomography-Based Selection of Transseptal Puncture Site for Percutaneous Left Atrial Appendage Closure

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Peripheral intravascular lithotripsy for transcatheter aortic valve implantation: a multicentre observational study

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Adolescents and adults with Fontan circulation: insights from the PREpArE-Fontan registry

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. Atrial fibrillation after closure of patent foramen ovale in the REDUCE clinical study

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

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.

Original languageEnglish
JournalCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Volume97
Issue number7
Pages (from-to)E1011-E1018
ISSN1522-1946
DOIs
Publication statusPublished - 1 Jun 2021

    Research areas

  • atrial fibrillation, closure, device, left atrial appendage, preclinical testing

ID: 62239925