W.L.Gore & Associates
The MBA 25-04 study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to assess the initial safety of the MBA device through five years following the index endovascular procedure.
This study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to collect outcomes for subjects treated with the MBA device through five years following the index endovascular procedure. Due to the early feasibility phase of the study, this study utilizes a non-randomized single-arm design with descriptive outcomes, with the primary objective of providing initial safety data. A maximum of 14 clinical investigative sites in the U.S. and Europe will participate in this study, with up to 12 sites located in the U.S., and up to 2 sites located in Europe. E…
Inclusion Criteria: The subject is / has: 1. Thoracic pathologies with involvement of the arch branch vessels, that are compatible with the treatment requirements of the MBA device, and meeting any of the following criteria: a) Aneurysm and Isolated Lesions: i. Fusiform aneurysm (≥ 55 mm or documented growth rate \> 0.5 cm/year). ii. Saccular aneurysm (no diameter criteria). iii. Pseudoaneurysms (\> 30 days post-surgery, no diameter criteria). iv. Penetrating Aortic Ulcers (PAUs) without intramural hematoma (IMH) (no diameter criteria). b) Aortic dissection: i. Uncomplicated and high…
Primary Investigational Device
Secondary Investigational Device
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