W. L. Gore & Associates received FDA approval for its Conformable GORE TAG Thoracic Endoprosthesis to be used for repair of acute and chronic Type B dissections of the descending thoracic aorta. The device allows for procedures that would otherwise require a fully open thoracic approach.
The GORE TAG received its initial approval from the FDA a year and a half ago for treatment of isolated lesions of the descending thoracic aorta.
From the announcement:
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.
Product page: Conformable GORE TAG…