An Endovascular Therapy Breakthrough: The Conformable GORE TAG Device Receives FDA Approval for Treatment of Type B Aortic Dissections

Editor's Corner

Submitted on Mon, 11/04/2013 - 14:59
Authors

Frank J. Criado, MD, FACS, FSVM

Gore Medical announced on September 11, 2013, that the US Food and Drug Administration has approved the Conformable GORE TAG Thoracic Endoprosthesis (C-TAG) for endovascular repair of acute and chronic type B dissections of the descending thoracic aorta. This represents the first regulatory approval for treatment of aortic dissection and a remarkable step forward in strengthening the claim that thoracic endovascular aortic repair (TEVAR) has come of age. The Medtronic Valiant device is expected to receive the next such approval in the very near future.

Performance of TEVAR intervention for type B aortic dissections has gradually increased over the last 10 years or more. However, it was – notoriously – an off-label use of thoracic stent-grafts and, as such, device manufacturers were forbidden from promoting the therapy, engaging in educational or training activities, or even talking about it! The situation will rapidly change for the better now as aortic dissection has become an approved on-label indication.

Industry and physicians alike will now feel free to share clinical information and engage in educational and training activities on this very important disease for TEVAR therapy overall. Better yet, more resources will become available to further our knowledge and produce the required evidence to create a more solid foundation for modern management of type B aortic dissection. While many significant challenges remain, the future couldn’t be brighter!