On 13 January, The US Food and Drug Administration (FDA) expanded the approved usage for Gore’s TAG Thoracic Endoprosthesis to include treatment of life-threatening tears or thoracic aortic transection.
The TAG Thoracic Endoprosthesis is the first endovascular graft approved by the FDA to treat a variety of thoracic lesions, including aneurysms as well as thoracic aortic transections. The expanded approval of this endovascular graft provides surgeons with a minimally invasive and potentially less risky alternative to open chest surgery for the treatment of thoracic aortic transection and other lesions.
The FDA based its expanded approval on data from 51 patients implanted with the Gore TAG to treat thoracic aortic transection caused by trauma. Patients were monitored for 30 days with physician exams and follow-up X-ray and CT scans. All survived the implant procedure; four patients died from causes unrelated to the device or implant procedure. The company will continue to follow patients for five years.
“The FDA commends the manufacturer for recognising the need to expand the indication of Gore TAG and for proactively working to obtain the safety and effectiveness data needed to support it,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health.
This is the only FDA approved thoracic endoprosthesis specifically designed to treat the anatomy of young trauma patients, with the ability to treat down to 16 mm aortas and extremely tapered anatomy. The device offers conformability and ease of use, while accommodating tapered anatomy and resisting compression. The broad oversizing window for the device ranges from 6 to 33%, allowing physicians to choose the appropriate oversizing for the patient anatomy.
“We gained a great deal of insight and knowledge from the traumatic transection trial for Conformable Gore TAG device that ultimately led to the expansion of indications. Through the research, we were able to illustrate the capabilities of the device, and help to demonstrate that thoracic endografts can offer patients with traumatic aortic transection a less invasive alternative to open surgical repair.” Mark Farber, director of the Aortic Center at the University of North Carolina at Chapel Hill, said, he also served as national principal investigator for Gore TAG device in the Traumatic Aortic Transection Trial (Gore TAG 08-02).
FDA first approved the Gore TAG in 2005 to treat aortic aneurysms to reduce the risk of rupture. The expanded approval represents the latest design, which features materials that conform to the bends and angles common in the area where thoracic aortic transections typically occur.
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.