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Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE Excluder Thoracoabdominal Branch Endoprosthesis | Device | TEVAR |
|
• 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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic Arizona |
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| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Keck Medical Center of USC | Los Angeles | California | 90033 | United States |
| Kaiser Permanente San Francisco Medical Center | San Francisco | California | 94118 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| MedStar Health Research Institute - MedStar Washington Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida - Gainesville | Gainesville | Florida | 32610 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Indiana University | Indianapolis | Indiana | 46226 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan - Cardiac Surgery | Ann Arbor | Michigan | 48109 | United States |
| Essentia Health | Duluth | Minnesota | 55805 | United States |
| Division of Vascular Surgery - Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Mount Sinai West | New York | New York | 10019 | United States |
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
| University of Rochester | Rochester | New York | 14627 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Sanger Heart & Vascular Institute | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| UPP Heart and Vascular Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Tennessee -University Vascular Surgeons | Knoxville | Tennessee | 37920 | United States |
| St. David's Healthcare | Austin | Texas | 78705 | United States |
| Baylor Heart & Vascular Hospital | Dallas | Texas | 75226 | United States |
| University of Texas Southwestern | Dallas | Texas | 75352 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| The Methodist Hospital - Houston | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center | Houston | Texas | 77030 | United States |
| Sentara Medical Group | Norfolk | Virginia | 23507 | United States |
| Carilion Clinic Hospitals | Roanoke | Virginia | 24014 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | United States |
| Aurora Health Care, Metro Inc. | Milwaukee | Wisconsin | 53215 | United States |