W.L. Gore & Assoc. said today that it enrolled the 1st patient in a pivotal study evaluating its Tag thoracic branch endoprosthesis as a treatment for lesions of the aortic branch and descending thoracic aorta.
The Tag TBE is the 1st Gore device to win the FDA’s expedited access pathway designation and among the 1st medical devices in the U.S. to do so, the Phoenix-based company reported. It’s also the 1st aortic branch device to participate in a pivotal study.
Gore said the 435-patient study is slated to enroll patients at 40 sites across the U.S.
“Based on the success in the feasibility and early feasibility studies, we are excited about this significant next step to treat a broader range of patients with this innovative device,” co-principal investigator Dr. Michael Dake said in prepared remarks.
“As a commercially available device, the TBE would offer new less-invasive treatment options for patients with aortic arch disease, which has traditionally challenged both open surgical and endovascular management,” added co-principal investigator Dr. Himanshu Patel. “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 1st 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,” aortic business leader Ryan Takeuchi added. “Following a legacy of ‘firsts’ for this device family, we are now the 1st to advance this therapy into the pivotal phase, allowing the treatment of challenging aortic arch pathologies with an off-the-shelf endovascular device.”