FDA Expands Indication for Gore Aortic Device

Gore Medical recently announced that the GORE^® TAG^® Thoracic Branch Endoprosthesis (TBE) received expanded FDA approval for use in Zones 0 and 1, widening its capabilities to include the endovascular repair of lesions in the aortic arch as well as the descending thoracic aorta. The device, which was proven in Zone 2 repair, preserves flow to a single aortic branch vessel, and now stands as the first off-the-shelf device of its kind indicated for Zones 0 to 2.

“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,” stated Michael Dake, MD, national co-principal investigator of the GORE TAG Thoracic Branch Endoprosthesis Clinical Trial in a press release. “Of the 77 patients enrolled in the Zone 0/1 pivotal trial, more than 90 percent 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.”

The TBE enables an “on-label alternative” surgical option to open surgical repair while reducing the impact of procedures such as sternotomy, cardiopulmonary bypass, and circulatory arrest, as noted by the investigators.

“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, said Jason Belzer, Americas Business Leader, Medical Products Division, Gore Medical.  “We are excited that more patients will have access to this technology.”