Technology | October 01, 2013

Gore Receives First FDA Approval for Endovascular Repair of Aortic Dissection

Conformable Gore TAG Thoracic Endoprosthesis first to receive indication for aneurysm, trauma and dissection

Gore FDA Approval Conformable Gore TAG Endovascular Repair of Aortic Dissection

October 1, 2013 — The U.S. Food and Drug Administration (FDA) approved the Conformable Gore TAG Thoracic Endoprosthesis for endovascular repair of acute and chronic Type B dissections of the descending thoracic aorta. The Conformable Gore TAG Thoracic Endoprosthesis is designed for multiple thoracic etiologies, and is the only device to receive FDA indications for aneurysm, trauma and dissection. Previously, the only approved treatment options were medical management or open surgical repair.

"Vascular surgeons have for some time awaited an approved indication for treating certain Type B aortic dissection patients since the consensus has been that endovascular stent graft repair has emerged as the treatment of choice," said Richard Cambria, M.D., chief, Division of Vascular and Endovascular Surgery and co-director, Thoracic Aortic Center at the Massachusetts General Hospital Vascular Center. “Now, surgeons will be able to present patients with a minimally invasive treatment option, and the exchange of information and experience among surgeons will be more acceptable now that the procedure is approved.”

“Having an FDA-approved Type B dissection indication is very important, as the impact this has on the endovascular community and the eligible patient population is huge,” said Joseph Bavaria, M.D., Roberts-Measey professor of surgery, vice chair in the Division of Cardiovascular Surgery and director of the Thoracic Aortic Surgery Program at the University of Pennsylvania. “I applaud Gore for recognizing the urgent need for an FDA-approved dissection indication and for being committed to conducting a thorough and expertly run clinical study.”

The Conformable Gore TAG Device offers conformability and ease of use while accommodating tapered anatomy. The device resists compression and has an oversizing window ranging from 6 to 33 percent. Physicians are able to choose the appropriate oversizing for the patient anatomy, which is particularly important in dissection patients due to the delicate nature of the disease.

The Conformable Gore TAG Thoracic Endoprosthesis is delivered via catheter, inserted into the femoral artery through a small incision in the groin and carefully guided up the leg artery through the abdomen into the chest and to the implantation site. The device is available in diameters of 21-45 mm, allowing for the treatment of patients with aortic diameters of 16-42 mm. Tapered device configurations are also available.

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