First Commercial Implant of the GORE® TAG® Thoracic Branch Endoprosthesis in Canada

The first flexible, off-the-shelf single-branch thoracic endoprosthesis for zone 2 treatment.

FLAGSTAFF, AZ (June 27, 2024) — W. L. Gore & Associates (Gore) today announced the first commercial use of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE) in Canada. The news comes in conjunction with Health Canada approval for this first-of-its-kind endovascular device, which is indicated to treat lesions of the descending thoracic aorta—while maintaining flow into the left subclavian artery (LSA)—in patients with appropriate anatomy.

Designed for thoracic endovascular aortic repair (TEVAR) procedures, the GORE TAG Thoracic Branch Endoprosthesis provides a minimally invasive option in patients requiring aortic treatment into zone 2 across the left subclavian artery.

For surgeons Randy Moore, M.D., Kenton Rommens, M.D., Scott McClure, M.D., Holly Smith, M.D. and Eric Herget, M.D. of the Calgary Aortic Program team at the University of Calgary, today marks a significant moment for physicians and the patients in their care.

“Traditionally, treating aortic arch disease has posed various challenges,” the team remarked in a statement. “Now, with a single device that can be used in a single procedure, we possess a powerful solution with the potential to simplify aortic treatment requiring coverage of the left subclavian artery.

Crucially, the ability to endovascularly perfuse the LSA plays a key role in minimizing the risks associated with surgical revascularization.”

The GORE TAG Thoracic Branch Endoprosthesis was the first FDA-approved off-the-shelf aortic branch device for treatment of zone 2 lesions evaluated in the U.S. The pivotal trial enrolled 238 patients in Zone 2 across multiple aortic pathologies, including aneurysm, dissection, traumatic transections and other isolated lesions. Overall technical success rate was 95.8% across all pathologies, through 30 days the disabling stroke rate was 1.7% and through 12 months the reintervention rate was 2.9%.¹

For Dr. Moore, “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.”

“Today sees us take another step on the path of progress in endovascular treatment,” added David Ferguson, president, Gore Medical, “building on more than 25 years of Gore experience in thoracic aorta innovation. It’s a path we’re proud to pave, and one we will continue to explore with open minds and close physician collaboration.”

The GORE TAG Thoracic Branch Endoprosthesis adds another member to a growing family of endovascular products, 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), as well as the GORE® EXCLUDER® Thoracoabdominal Branch Device (TAMBE), the first off-the-shelf endovascular solution for the treatment of complex aneurysmal disease involving the visceral aorta.

About Gore

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 55 million medical devices implanted, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. For more information, visit goremedical.com.

1. GORE TAG Thoracic Branch Endoprosthesis. [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2022. MD184153. Rev. 2.

For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU). Products listed may not be available in all markets.

GORE, Together, improving life, EXCLUDER, TAG and designs are trademarks of W. L. Gore & Associates.

24AR1070-EN01          JUNE 2024