Gore has announced that the Gore Tag thoracic branch endoprosthesis (TBE) is now approved by the US Food and Drug Administration (FDA) 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.
The device becomes the first off-the-shelf, single-branch thoracic endoprosthesis indicated across Zones 0, 1 and 2, enabling or expanding minimally invasive aortic repair of all lesions involving the arch, the company has stated in a recent press release.
“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,” said Michael Dake, national co-principal investigator of the Gore Tag TBE clinical trial. “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 endoleak.”
For Zone 0 and 1 procedure, TBE provides an on-label alternative to open surgical repair and reduces the overall impact of procedures like sternotomy, cardiopulmonary bypass and circulatory arrest.
“We’ve seen firsthand how this technology can transform patient care,” said Himanshu Patel, national co-principal investigator. “With a less invasive approach, we can reduce a significant procedural burden on patients.”
For Gore’s Jason Belzer, Americas business leader, Medical Products Division, “The expanded indication equips physicians with a versatile solution for the challenges of treating aortic arch pathologies—with the backing of rigorous data and a track record of procedural success. We are excited that more patients will have access to this technology.”
First approved in the USA in May 2022, this new indication for the use of TBE in Zones 0/1 further demonstrates how Gore is advancing the care of complex aortic disease with minimally invasive approaches for patients.
