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FDA Approves 45 mm Gore Tag Thoracic Endoprosthesis

WL Gore & Associates has received approval from the FDA to market a 45mm diameter version of the Gore Tag Thoracic Endoprosthesis for treatment of Thoracic Aortic Aneurysms (TAA).

Gore Tag Thoracic Endoprosthesis allows treatment of TAA with proximal and distal neck diameters ranging from 37 to 42mm and is available for commercial use in the US.

Gore said that the 45 mm Gore Tag Device is available in 10, 15 and 20cm lengths. In addition, all Gore Tag Devices, including the 45mm device, are delivered on a modified device delivery catheter that is designed for enhanced trackability and deliverability.

The modified Gore Tag Device delivery catheter is a simple, single-step deployment system engineered to optimise placement and control. The novel sheathless delivery catheter provides flexibility for navigating tortuous anatomy and low deployment forces.

The Gore Tag Device internally relines the thoracic aorta and isolates the diseased segment from blood circulation. The Gore Tag Device is comprised of an ePTFE graft with a self-expanding nitinol support structure to combine both device flexibility and material durability. The device is inserted via a catheter delivery technique through a small incision in the patient’s groin.

Gore claimed that the device is the only endovascular thoracic device with more than 10 years of worldwide commercial data. Five year follow-up data from the clinical study indicates that subjects treated with the Gore Tag Device have improved aneurysm-related survival and a consistently lower incidence of major adverse events compared to subjects treated with open surgical repair.

David Abeyta, aortic business unit leader at Gore, said: “The larger diameter Gore Tag Device provides physicians with a safe and effective way to treat TAA in patients with larger neck diameters. This is an endovascular option for treating TAA with proven results and benefits to the patient, and we look forward to continuing to provide innovative solutions for thoracic and other conditions moving forward.”

Gore family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement, and sutures for use in vascular, cardiac and general surgery.