Gore aortic arch implant gets OK for study

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Limited use. Apply text "CAUTION: Investigational use only. Limited by United States Law to Investigational Use."
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Limited use. Apply text "CAUTION: Investigational use only. Limited by United States Law to Investigational Use."
Limited by United States Law to Investigational Use.”

W.L. Gore & Associates, Inc. announced the first implant of the  Gore Tag Thoracic Branch Endoprosthesis.

Gore is based in Newark, with its medical unit based in Flagstaff, AZ.

The patient was enrolled by Himanshu Patel, MD, section head of adult cardiac surgery at the University of Michigan Frankel Cardiovascular Center and co-national principal investigator.

The objective of the study is to determine the safety and efficacy of the TBE in treating lesions of the aortic arch, the part of the aorta between the ascending and descending aorta.

The study will include up to 40 sites across the U.S. that are expected to recruit up to 435 patients.

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“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,”  Patel said. “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.”

According to Gore, Aortic arch disease has traditionally been difficult to treat. The options   require complex procedures.

The  TBE is the first Gore device to receive the new FDA Expedited Access Pathway  designation and among the first medical devices to receive this designation in the U.S.

This pathway is limited to certain medical devices that demonstrate the potential to address unmet medical needs for life-threatening diseases and offer a meaningful patient benefit compared to existing alternatives.

“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,” said Ryan Takeuchi, Aortic Business Leader at Gore. “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.”

Gore,  has provided  solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical Devices have been implanted.

Products include vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery.

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