In January 2012, the US Food and Drug Administration (FDA) approved the redesigned Conformable GORE® TAG® Device (Gore & Associates, Flagstaff, AZ) for the treatment of isolated lesions of the descending thoracic aorta. This new indication adds to the already approved indication of aneurysmal disease. However, the new indication may be somewhat confusing to many vascular specialists because the term “isolated lesion” has not been clearly defined.

As improved axial imaging techniques replace traditional modalities such as angiography for evaluation of the thoracic aorta, aortic specialists have recognized subtler pathologies involving the wall of the aorta. No longer are only the terms aneurysm, transection, and dissection used to describe the pathologic process that afflicts the area. Additional terms, such as penetrating atherosclerotic ulcer, intramural hematoma, intimal disruption, focal dissection, and isolated injuries, have been identified. Although these lesions can occur in other regions of the aorta, they are often limited to the descending thoracic aorta.

DEFINING ISOLATED LESIONS

If normal aortic sections exist above and below a concerning lesion, allowing for endovascular treatment distal to the left common carotid artery and proximal to the celiac artery, then the term “isolated lesion of the descending thoracic aorta” can be used to describe the lesion. This broader term expresses the many different disease processes that the vascular specialist may encounter and creates an environment in which endovascular treatment is appropriate. It should be noted that extensive pathologies, such as dissections, are generally excluded from the definition given the typical extent of disease and pathologic implications. Instead, for the Conformable GORE® TAG® Device, the FDA has considered the multitude of pathologies that have been tested in clinical trials and sees endovascular treatment as safe and appropriate when the disease is limited to the descending aorta.

CONCLUSION

This approach to defining “indications for use” based on pathology limited to an anatomic location condition is a more practical approach to endovascular therapy than the previously restrictive method based on specific pathologies. The multiple studies on endovascular thoracic aortic disease gave the FDA an overview of the common problems seen by vascular specialists and led to the approval of the broader indication for use of the Conformable GORE® TAG® Device. Continued collaborative efforts with the FDA in clinical trials and the pursuit of device approval will likely bring additional alternative therapies to patients.

William Jordan, MD, is a professor and Section Chief of Vascular Surgery and Endovascular Therapy with the University of Alabama at Birmingham, in Birmingham, Alabama. He has disclosed that he has received research support from and is a consultant to Gore & Associates, Aptus Endosystems, Inc., Endologix, Inc., Lombard Medical, and Medtronic, Inc. Dr. Jordan may be reached at (205) 934-2006; wdjordan@uab.edu.

Mark Farber, MD, FACS, is Director of the UNC Aortic Center and Associate Professor of Surgery and Radiology at the University of North Carolina in Chapel Hill, North Carolina. He has disclosed that he is a consultant for Gore & Associates, Bolton Medical, and Cook Medical. Dr. Farber may be reached at (919) 966-3391; mark_farber@med.unc.edu.