FDA Approval for Commercial Large-Diameter Thoracic Tapered Implant

The US Food and Drug Administration (FDA) has approved W.L. Gore & Associates four new large-diameter tapered designs for the GORE TAG Comfortable Thoracic Stent Graft with ACTIVE CONTROL System: 34×28 mm, 37×31 mm, 40×34 mm, and 45×37 mm.

This approval is associated with the first US commercial implant, designed at the Keck School of Medicine at USC by Sukgu Han, MD, MS, chief of the Division of Vascular Surgery and Endovascular Therapy at USC. According to Dr. Han, the newly approved taper sizes “provide a welcome addition to the available treatment options for patients and expand the applicability for the existing Gore technologies.

First approved in 2019, the GORE TAG Comfortable Thoracic Stent Graft with ACTIVE CONTROL System provides a staged delivery system indicated for endovascular repair of all lesions of the descending thoracic aorta (including aneurysms, transections, and type B dissections).

Dr. Han also noted, “The right decision sizing is always critical, especially when treating in the narrow true lumen. These additional tapered designs will help us achieve optimal sizing for a broader range of aortic diameters while continuing to leverage the proven performance and properties of this device system.”

Reference

GORE Press Release