FDA Regulatory Review Scientist Dorothy B. Abel discusses what led to the unique expanded approval of a thoracic endograft and a landmark postapproval study.
In September 2013, the US Food and Drug Administration (FDA) broadened its approval of the Gore TAG thoracic endoprosthesis (Gore & Associates, Flagstaff, AZ) to remove the exclusion of repair of dissections of the descending thoracic aorta from the indications for use. Originally approved for the treatment of aneurysms in the descending thoracic aorta (its previous iteration having received the first thoracic approval in 2005), the device’s approval was previously expanded to the repair of isolated lesions of the descending thoracic aorta, a designation that included all types of isolated lesions (eg, traumatic transections, intramural hematomas, penetrating ulcers), but excluded dissections.
The pathway that led to these approvals was unique. FDA regulatory agents, leading aortic experts from a variety of specialty backgrounds, and industry representatives with otherwise competing interests worked collaboratively over a number of years with a common goal of identifying the outstanding questions with the endovascular treatment of thoracic aortic pathologies and the appropriate mechanisms to answer these questions. Some will be addressed postmarket using an innovative postmarket study. To learn more about the approval pathway and the goals of the postapproval study, Endovascular Today asked Dorothy B. Abel to share her insights.