Gore TAG TBE Approved for Zones 0 and 1 Aortic Arch Repair

June 23, 2025—Gore & Associates announced that the company’s TAG thoracic branch endoprosthesis (TBE) has received FDA approval for use in zones 0 and 1, expanding its indication for the endovascular repair of lesions in the aortic arch and descending thoracic aorta while preserving flow to a single aortic arch branch vessel.

According to Gore, TBE for zone 0 and 1 procedures provides an on-label alternative to open surgical repair and reduces the overall impact of procedures like sternotomy, cardiopulmonary bypass, and circulatory arrest.

In May 2022, the FDA approved the off-the-shelf, single-branch TBE for use in zone 2. Now, with approved indications across zones 0, 1, and 2, the device enables minimally invasive aortic repair of all lesions involving the arch, stated the company.

Michael Dake, MD, and Himanshu Patel, MD, are National Coprincipal Investigators of the Gore TAG TBE clinical trial (zone 0/1).

“With broader indications, we can confidently address a wider range of complex arch pathologies using a trusted solution that streamlines procedure planning and—critically—helps improve patient outcomes,” commented Dr. Dake in Gore’s press release. “Of the 77 patients enrolled in the zone 0/1 pivotal trial, more than 90% were treated in zone 0 with no instances of device migration or wire fracture through 12 months, as well as low rates of type I and III endoleaks.”

Dr. Patel added, “We’ve seen firsthand how this technology can transform patient care. With a less invasive approach, we can reduce a significant procedural burden on patients.”