Gore starts its pivotal trial of the first device intended specifically to treat aortic arch disease in a less-invasive manner.
The Gore TAG Thoracic Branch Endoprostheis has FDA Expedited Access Pathway designation and is being studied in a pivotal trial.
The Gore TAG Thoracic Branch Endoprosthesis (TBE) device, which is designed to treat lesions of the aortic arch and descending thoracic aorta less invasively, has entered a pivotal trial. W.L. Gore & Associates, Inc., the makers of the TBE, announced implants have begun, with the first TBE patient enrolled at the University of Michigan Frankel Cardiovascular Center.
This study is meaningful because if eventually approved, the TBE would be the first device to offer aortic arch treatment in a less-invasive manner. Instead of requiring open surgery, the TBE allows physicians to deliver the graft using a catheter inserted into the femoral artery. This endovascular repair approach is already popular for treating abdominal aortic aneurysms.
As noted in the Gore press release, patients with aortic arch disease typically undergo either open surgery, a hybrid treatment with surgical revascularization, or procedures that use endovascular devices off label. FDA has granted Gore's TBE the Expedited Access Pathway designation, which is reserved for devices that address unmet needs and offer meaningful benefit for patients with life-threatening conditions.
Around the aortic arch, the aorta is divided into different "zones" by the braciocephalic artery (BCA), the left common carotid artery (LCCA), and the left subclavian artery (LSA). Zone 0 is the portion of the ascending aorta below the BCA, Zone 1 is located between the BCA and LCCA, and Zone 2 is the portion of the aortic arch between the LCCA and the LSA. The pivotal trial will include up to 435 patients at up to 40 U.S. sites and all of the patients need treatment for lesions in Zone 0-2.
Gore's device is an off-the-shelf device that includes a side branch component—necessary to ensure a branch vessel isn't blocked and continues to have normal blood flow.
Himanshu Patel, MD, section head of adult cardiac surgery at the Frankel Center and co-national principal investigator who enrolled the first TBE patient in the trial, said in the release, "The conformability of the GORE® TAG® Device combined with the unique side branch design provides a less-invasive treatment of the aortic arch with opportunities for perfusion of the brachiocephalic, left common carotid, or left subclavian arteries."
"The first implant of the TBE in the pivotal study is the latest step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market," Ryan Takeuchi, Aortic business leader at Gore, said in the company release. "Following a legacy of 'firsts' for this device family, we are now the first to advance this therapy into the pivotal phase, allowing the treatment of challenging aortic arch pathologies with an off-the-shelf endovascular device."
[Image courtesy of W.L. GORE]