Conformable Gore TAG's FDA Approval Becomes First to Include Endovascular Repair of Aortic Dissection
September 11, 2013—Gore & Associates (Flagstaff, AZ) has announced that the US Food and Drug Administration (FDA) approval for the company’s Conformable Gore TAG thoracic endoprosthesis now includes endovascular repair of acute and chronic type B dissections of the descending thoracic aorta.
According to the company, the Conformable Gore TAG thoracic endoprosthesis is designed for multiple thoracic etiologies. It provides conformability and ease of use while accommodating tortuous and tapered anatomy. The Conformable Gore TAG resists compression and has a broad oversizing window ranging from 6% to 33%. 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, noted Gore.
The Conformable Gore TAG, which is delivered via transfemoral catheter, is available in diameters of 21 mm to 45 mm, allowing for the treatment of patients with aortic diameters of 16 mm to 42 mm. Tapered device configurations are also available.
Richard Cambria, MD, and Joseph Bavaria, MD, commented on the device in the Gore press release.
Dr. Cambria stated, “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. 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.”
Dr. Bavaria stated, “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. 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.”
Dr. Cambria is Chief, Division of Vascular and Endovascular Surgery and Co-Director, Thoracic Aortic Center at the Massachusetts General Hospital Vascular Center in Boston, Massachusetts. Dr. Bavaria is 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 in Philadelphia, Pennsylvania.
In March 2005, the Gore TAG endoprosthesis became the first endovascular device approved by the FDA for the treatment of thoracic aneurysms; the Conformable Gore TAG's approval for treatment of thoracic aneurysms was announced in November 2011. In January 2012, the company announced FDA approval of the Conformable Gore TAG for endovascular repair of isolated lesions of the descending thoracic aorta, including traumatic aortic transections.