Gore’s TAG Thoracic Branch Endoprosthesis Approved and Launched in Canada

June 27, 2024—Gore & Associates announced the Health Canada regulatory approval and the first commercial use in Canada of the company’s TAG thoracic branch endoprosthesis (TBE).

According to the company, the thoracic endovascular aortic repair (TEVAR) device is indicated to treat lesions of the descending thoracic aorta in patients with appropriate anatomy, while maintaining flow into the left subclavian artery (LSA). The device provides a minimally invasive option in patients requiring aortic treatment into zone 2 across the left subclavian artery.

In Gore’s press release, the Calgary Aortic Program team at the University of Calgary in Calgary, Alberta, provided a statement on the device. The Calgary team includes Randy Moore, MD; Kenton Rommens, MD; Scott McClure, MD; Holly Smith, MD; and Eric Herget, MD.

“Traditionally, treating aortic arch disease has posed various challenges,” stated the Calgary Aortic team. “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.”

In May 2022, the company announced United States FDA approval for the Gore TAG TBE. The United States 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%.

Dr. Moore commented on the pivotal trial in the press release, “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.”

In February 2024, Gore announced the first implantation of the TAG device in Europe after receiving CE Mark approval under the European Medical Device Regulation certification.