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First U.S. Use of FDA-Approved TAMBE Device Offers New Hope for Aortic Aneurysm Patients

• Intermountain Medical Center is the first in the U.S. to use the FDA-approved Gore EXCLUDER TAMBE device to treat aortic aneurysms, a potentially life-saving advancement. • The minimally invasive procedure eliminates the need for major surgery, reducing recovery time and complications for patients with complex aortic aneurysms. • The TAMBE device is the first readily available solution for treating aneurysms in the visceral aorta, providing blood to key abdominal organs. • Vascular surgeons at Intermountain Health have performed several successful TAMBE procedures, marking a significant step forward in vascular surgery.

Intermountain Medical Center in Murray, Utah, has become the first hospital in the United States to perform a minimally invasive procedure using the newly FDA-approved Gore EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) device. This marks a significant advancement in treating patients with aortic aneurysms, a condition that can be fatal if the aneurysm ruptures.
Intermountain Health vascular surgeon Evan Brownie, MD, hailed the TAMBE device as a "game changer." He performed the first commercial procedure using the device outside of clinical trial participants.

Minimally Invasive Solution

The TAMBE device offers a less invasive alternative to traditional open surgery for repairing aortic aneurysms, which are bulges in the aorta. Aneurysms are particularly dangerous due to the risk of rupture and subsequent life-threatening bleeding. The device is designed to treat complex aneurysms in the visceral aorta, which supplies blood to vital abdominal organs such as the liver, kidneys, spleen, stomach, and intestines.

Advantages Over Traditional Surgery

Previously, open thoracoabdominal aneurysm repair was the primary option, a highly invasive procedure involving a large incision. Dr. Brownie described the open surgery as taking a significant physical toll on the body, with long recovery times and high complication risks. In contrast, the TAMBE device is delivered through small punctures in the femoral arteries in the groin and one beneath the collarbone, deploying a custom stent graft with individual branches to supply blood to the affected organs.

Eliminating Off-Label Device Modifications

Prior to the availability of TAMBE, surgeons often had to modify existing devices or use off-label techniques to treat these complex cases, leading to unpredictable outcomes. The TAMBE device eliminates this need, providing an FDA-approved, off-the-shelf solution specifically designed for complex aortic aneurysms.

Promising Early Results

Since the initial procedure at Intermountain Medical Center, Intermountain Health vascular surgeons have performed several more cases with promising results. "We're at the forefront of something truly significant, and it's exciting to be part of a new era in treating these complex and dangerous aneurysms," said Dr. Brownie.
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Reference News

[1]
Intermountain Medical Center First in Nation to Use FDA-Approved Device to Treat Life ...
news.intermountainhealth.org · Oct 15, 2024

Intermountain Medical Center is the first to use the FDA-approved Gore EXCLUDER Thoracoabdominal Branch Endoprosthesis (...

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