Cooper is one of only a handful of hospitals in the tri-state region—and fewer than 40 nationwide—participating in a pivotal study of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE), the first device designed specifically for the endovascular treatment of aortic arch lesions.
It offers a minimally invasive treatment for patients with these more complicated aortic aneurysms.
“Technology came out about 20 years ago that enabled us to endovascularly repair aortic aneurysms below the kidney arteries,” says vascular surgeon Joseph V. Lombardi, MD, FACS, head of the Division of Vascular and Endovascular Surgery and director of the Cooper Aortic Center.
“But the technology has developed slowly for treating thoracic aneurysms and aortic arch disease,” he continues. “While we can treat many thoracic and thoracoabdominal aneurysms with an endovascular stent graft, there are limitations when the aortic arch is involved. As a result, these patients have required open surgical procedures.”
Not any more—if this new clinical study lives up to its promise. The objective of the study is to determine the safety and efficacy of the TBE in treating lesions of the aortic arch and descending thoracic aorta, which includes dissection, trauma or aneurysm.
This pivotal study follows both an early feasibility study conducted in Zones 0-1 with the branch device in the brachiocephalic or left common carotid arteries, and a feasibility study in Zone 2 with the branch device in the left subclavian artery. The new pivotal study will include up to 40 sites across the U.S. that are expected to recruit up to 435 patients, treating all etiologies requiring proximal graft placement in Zones 0-2.
“Through this trial, we can treat these arch aneurysms, or thoracic aneurysms with arch involvement, endovascularly, through the groin,” Dr. Lombardi explains. “We don’t have to put the patient on cardiopulmonary bypass or crack the chest, and potentially reduce associated complications resulting in these existing methods of access.”
Bottom line, as a commercially available device—which it already is in Europe—the TBE could offer an important less-invasive treatment option for the population of U.S. patients with aortic arch disease, a condition that traditionally has posed significant challenges for both open surgical and endovascular management.
The limited options currently available for treating patients with aortic arch disease is one of the reasons that the TBE is the first GORE device to receive the new FDA Expedited Access Pathway (EAP) designation, and among the first medical devices to receive this designation in the U.S. This pathway is limited to certain medical devices that demonstrate the potential to address unmet medical needs for life-threatening diseases and offer a meaningful patient benefit compared to existing options.
“There’s a commitment on the part of the Cooper Aortic Center to introduce new technology to the South Jersey community that enables us to treat more complicated aneurysms,” Dr. Lombardi says. “This trial represents a major milestone in our ability to do just that.
“The company that makes this device (W.L. Gore & Associates, Inc.) is meticulous about the hospitals they select to participate in this trial,” he adds, noting that selection is based on surgical expertise, volume, and national stature. “So being chosen for this trial speaks loudly about the quality of Cooper’s aortic program.”
If you have questions about this study or a patient’s eligibility for enrollment, call Dr. Lombardi at 856.968.7067 or email Lombardifirstname.lastname@example.org.