Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe andeffective in the treatment of thoracoabdominal and pararenal aneurysms.
Gore will permit the use of the TAMBE Device in a manner consistent with the approved CIP
provided that its use is needed to treat a serious, but non-life-threatening condition.
In the requesting physician's opinion, there must be no acceptable alternative treatment
option. Patients are to be consented with an Emergency / Compassionate Use ICF template
provided by Gore upon request for this type of device use. Sites will be required to fill
out a packet justifying the rationale of use as well as their plan to conduct follow-up
surveillance on the non-study subject. Upon performance of the case, the site will
immediately notify Gore and provide supporting documentation to facilitate timely,
compliant regulatory reporting.
Device: GORE Excluder Thoracoabdominal Branch Endoprosthesis
TEVAR
Other Name: TAMBE
• Aortic aneurysm involving the visceral vessels requiring treatment defined as at least
one of the following: Fusiform aneurysm diameter ≥ 5 cm Saccular aneurysm (no diameter
requirement) Rapid aneurysm growth (≥ 5 mm in one year)
- An Informed Consent Form signed by Subject or legal representative
- Appropriate aortic anatomy to receive the TAMBE Device d
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Division of Vascular Surgery - Minneapolis Heart Institute
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Mayo Clinic - Rochester
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Lebanon, New Hampshire, United States
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University of North Carolina
Chapel Hill, North Carolina, United States
Sanger Heart & Vascular Institute
Charlotte, North Carolina, United States
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Cleveland Clinic
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Philadelphia, Pennsylvania, United States
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University of Tennessee -University Vascular Surgeons
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Cardiothoracic and Vascular Surgeons, PA (CTVS)
Austin, Texas, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
University of Texas Southwestern
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Houston, Texas, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
Aurora Health Care, Metro Inc.
Milwaukee, Wisconsin, United States