YNHH performs first FDA-approved TAMBE procedure in Connecticut
Yale surgeons introduce a minimally invasive approach for complex aortic aneurysms.

YuLin Zhen, Photography Editor
Yale surgeons have completed Connecticut’s first FDA-approved TAMBE procedure, marking a shift in the treatment of complex aortic aneurysms.
On Aug. 7, vascular surgeons at Yale New Haven Hospital performed the state’s first Gore Excluder Thoracoabdominal Branch Endoprosthesis — TAMBE — procedure on a patient with a complex aortic aneurysm. The patient experienced a smooth recovery and was discharged within a few days. This minimally invasive procedure is now an option for complex aortic aneurysm patients, offering an alternative to traditional high-risk open surgery.
“This revolutionary technique promises to significantly improve outcomes for our aneurysm patients,” said Dr. David Kuwayama, director of aortic surgery in Yale’s Division of Vascular Surgery and Endovascular Therapy.
Thoracoabdominal aneurysms are enlargements of the aorta involving branch vessels to the kidneys, intestines and liver. Traditionally, these aneurysms required open surgery, which posed significant risks and lengthy recovery times, particularly for older or high-risk patients.
Endovascular techniques have gradually expanded treatment options. However, limitations in available grafts meant that many patients still faced high-risk surgeries or received off-label graft modifications. According to Dr. Kuwayama, this presented a challenge, especially for patients with conditions like atherosclerosis, heart disease or lung disease, who often could not withstand major surgery.
As a minimally invasive alternative, TAMBE aims to address complex aneurysms that extend to branch vessels, which has been a challenge with previous devices. It aims to maintain blood flow to vital organs while sealing the aneurysm, preventing rupture. Dr. Kuwayama described the previous solution for these complex cases as off-label, physician-modified grafts, which lacked the rigorous quality controls of commercial devices.
“We were burning holes into tubular grafts ourselves, which raised concerns about device integrity,” he said. “TAMBE is a game-changer, providing an FDA-approved, rigorously tested device that addresses this unmet need.”
The device’s FDA approval expands TAMBE’s use beyond clinical trials, making it more widely accessible. However, its implementation comes with challenges. Dr. Kuwayama highlighted the complexity of the procedure, emphasizing that it requires significant expertise and should be performed at specialized centers. TAMBE procedures involve precise imaging and catheter manipulation through the patient’s arteries, typically from the groin to the upper body, to deploy and secure the device.
Dr. Raul Guzman, chief of the Division of Vascular Surgery at Yale, noted that the procedure represents an important development in patient outcomes for complex aneurysms. He emphasized that while TAMBE can significantly reduce recovery time, further investigation is needed to determine the long-term durability of the device.
“Early outcomes have been promising,” Dr. Guzman said, “but constant monitoring and potential follow-up interventions are needed, unlike open repairs, which tend to be more definitive.”
Despite the advancements, ongoing data collection is still needed to ensure TAMBE’s safety and effectiveness across different clinical settings, Dr. Kuwayama echoed Guzman.
The representative of GORE, which developed the device, emphasized that careful rollout and training will be essential to avoid complications as TAMBE becomes more widely used.
The minimally invasive nature of the TAMBE procedure allows patients to recover more quickly compared to traditional open surgery. Dr. Kuwayama shared that many patients are expected to return home within two days, with a recovery period lasting about a week.
However, the TAMBE procedure is not suitable for everyone.
“Anatomical features, like narrow access vessels or unfavorable angles in branch arteries, can make implantation impractical,” Dr. Kuwayama said, adding that only about half of thoracoabdominal aneurysm patients might qualify for TAMBE treatment.
Careful patient selection is crucial to the procedure’s success. To determine whether the procedure is feasible, surgeons must assess the size and alignment of branch vessels and the structural integrity of the aorta.
GORE collaborated with Yale, as Dr. Kuwayama was previously involved in TAMBE’s clinical trials, allowing for the device’s early implementation in Connecticut.
Yale’s infrastructure and expertise played a significant role in TAMBE’s introduction. Dr. Guzman added that the hospital’s collaborative approach, which integrates cardiac and vascular specialties, sets it apart in providing comprehensive aortic care.
According to Dr. Kuwayama, the ongoing collaboration with device manufacturers will be essential as more technologies like TAMBE become available.
“We expect this to be just the first of many minimally invasive solutions in the pipeline,” he said. “Future devices may include grafts with more branches or features that enable fully groin-based delivery, expanding treatment options.”
L. Gore & Associates, Inc.’s privately held corporation is headquartered in Newark, Delaware.