W. L. Gore & Associates (Gore) has announced that the US Food and Drug Administration (FDA) has approved the Conformable GORE® TAG® Thoracic Endoprosthesis for endovascular repair of acute and chronic Type B dissections of the descending thoracic aorta. This durable endoprosthesis is the only device to receive FDA approval for this indication. The Conformable GORE TAG Thoracic Endoprosthesis is designed for multiple thoracic etiologies. Extensive clinical research has been conducted with the device and it is the one and only device to receive FDA indications for aneurysm, trauma and dissection.
An aortic dissection is the tearing of the innermost layer of the aortic wall, allowing blood to flow between the inner and outer layers of the vessel wall causing separation. If not stabilized, the dissection can increase the risk of rupture, cause complications with blood flow to the lower body and harm nearby organs. Until now, 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, MD, Chief, Division of Vascular and Endovascular Surgery and Co-Director, Thoracic Aortic Center at the Massachusetts General Hospital Vascular Center in Boston. "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, MD, 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 tortuous and tapered anatomy. The device resists compression and has a broad 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 and 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.
"Today's approval further advances the use of endovascular devices as standard of care and allows more patients to benefit from this preferred treatment option," said Ryan Takeuchi, Gore Aortic Business Leader. "Gore has always been on the cutting edge of endovascular treatment and was the first to gain approval for thoracic aortic aneurysm followed by aortic traumas using our Conformable GORE TAG Device. We are proud to offer surgeons another first with the only FDA-approved, minimally invasive treatment for Type B dissections."