FLAGSTAFF, Ariz. (MAY 13, 2022) — W. L. Gore & Associates (Gore) today announced that the U.S. Food and Drug Administration (FDA) approved the GORE® TAG® Thoracic Branch Endoprosthesis (TBE) for the endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery (LSA), in patients that are at high risk for LSA debranching procedures and have appropriate anatomy. As the first flexible, off-the-shelf single-branch thoracic endoprosthesis for patients requiring zone 2 treatment, this device is designed for minimally invasive thoracic endovascular aortic repair (TEVAR) procedures.
The approval is supported by data from the GORE® TAG® Thoracic Branch Endoprosthesis Pivotal Study (NCT02777593) evaluating the safety and efficacy of the TBE in treating lesions of the aortic arch and descending thoracic aorta.
“The GORE® TAG® Thoracic Branch Endoprosthesis has the potential to simplify the treatment of zone 2 LSA revascularization because it is a single device that can be used in a single procedure,” said Michael Dake, M.D., Senior VP for the University of Arizona Health Services, and co-national principal investigator. “The ability to endovascularly perfuse the left subclavian artery plays a key role in minimizing surgical procedures and related risks.”
“The results of the study were very encouraging for a variety of patients across aortic pathologies.”
Himanshu Patel, M.D.Frankel Cardiovascular Center, University of Michigan
In the pivotal study, 238 patients were enrolled across multiple aortic pathologies, including aneurysm, dissection, traumatic transection and other isolated lesions. All subjects were enrolled with a technical success rate of 95.8%, reintervention rate of 2.9% through 12 months and disabling stroke rate of 1.7% through 30 days.1
“The results of this study, which importantly measured both device technical success and the absence of select adverse events in zone 2 subjects, were very encouraging for a variety of patients across aortic pathologies,” said Himanshu Patel, M.D., section head of adult cardiac surgery at the University of Michigan Frankel Cardiovascular Center and co-national principal investigator.
“As the first flexible, off-the-shelf single branch thoracic endoprosthesis for the aortic arch, the TBE Device combines the proven conformability and durability of the Conformable GORE® TAG® Device with the ability to endovascularly perfuse the left subclavian artery,” said Eric Zacharias, Medical Products Division Leader at Gore. “This approval is another step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market.”
The GORE® TAG® Thoracic Branch Endoprosthesis was the first off-the-shelf aortic branch device to participate in a pivotal study and builds on more than 20 years of Gore experience in thoracic aorta innovation. TBE was designed with a pre-cannulated delivery system to improve ease of implantation and minimize the risk of branch vessel coverage.
The GORE® TAG® Thoracic Branch Endoprosthesis is part of the growing family of endovascular products that share a mission to effectively treat aortic disease, backed by Gore’s dedicated clinical support team and educational offerings. The comprehensive portfolio of products includes the first FDA-approved off-the-shelf iliac branch device, the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.* To round out the branched portfolio, studies are ongoing in the U.S. and Brazil for the GORE® EXCLUDER® Thoracoabdominal Branch Device (TAMBE), an investigational device. TAMBE is currently in Pivotal Clinical Trial and currently being studied under an IDE.
Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 50 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives.
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world’s highest peaks to the inner workings of the human body. With more than 11,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $3.8 billion.
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* For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use.
1. GORE® TAG® Thoracic Branch Endoprosthesis. [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc. 2022; MD184153. Rev. 1.
GORE® TAG® Thoracic Branch Endoprosthesis
Indications for use in the U.S.: The GORE® TAG® Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery, in patients who are at high risk for debranching subclavian procedures and have: Adequate iliac/femoral access; Proximal Aortic Landing Zones: For Isolated Lesion Patients: Proximal landing zone cannot be aneurysmal, dissected, heavily calciﬁed, or heavily thrombosed; For Dissection Patients: Primary entry tear must be distal to the left subclavian artery and the proximal extent of the landing zone must not be dissected; Aortic inner diameter range 16-42 mm; Proximal segment length (length from distal edge of left subclavian artery to mid left common carotid ostium) of at least 2.0-4.0 cm, depending on Aortic Component selection; Proximal covered length (measured from distal edge of left subclavian artery to distal edge of left common carotid artery ostium) of at least 15–36 mm, depending on Aortic Component selection; For patients with prior ascending aorta or aortic arch repair with a surgical graft: at least 2 cm landing zone proximal to the distal anastomosis; Left Subclavian Landing Zone: Not aneurysmal, dissected, heavily calcified, or heavily thrombosed and without severe tortuosity (180 degree turn within the treated length); Left subclavian artery inner diameter of 6–18 mm, depending on Side Branch Portal diameter selected; Left subclavian artery minimum length of 2.5–3.0 cm, depending on Side Branch Portal diameter selected. Distal Landing Zone (Isolated Lesion Patients only): Outer curve length must be ≥ 2 cm proximal to celiac artery; Aortic inner diameter range 16-42 mm; Non aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone; Native Aorta or previously placed GORE® TAG® Conformable Thoracic Stent Graft. Contraindications: The GORE® TAG® Thoracic Branch Endoprosthesis is contraindicated in: Patients with known sensitivities or allergies to the device materials [ePTFE (polytetrafluoroethylene), FEP (Fluoroethylpropylene), Nitinol (Nickel, Titanium), Gold, SB Component only - Heparin (CBAS® Heparin surface]; Patients who have a condition that threatens to infect the graft; Patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly
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