Gore recently announced that the US Food and Drug Administration (FDA) has approved the Gore Tag thoracic branch endoprosthesis (TBE) for the endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery (LSA), in patients that are at high risk for LSA debranching procedures and have appropriate anatomy. As the first flexible, off-the-shelf single-branch thoracic endoprosthesis for patients requiring zone 2 treatment, according to Gore, this device is designed for minimally invasive thoracic endovascular aortic repair (TEVAR) procedures.
A company press release states that the approval is supported by data from the Gore Tag thoracic branch endoprosthesis pivotal study evaluating the safety and efficacy of the TBE in treating lesions of the aortic arch and descending thoracic aorta.
“The Gore Tag thoracic branch endoprosthesis has the potential to simplify the treatment of zone 2 LSA revascularisation because it is a single device that can be used in a single procedure,” said Michael Dake, senior VP for the University of Arizona Health Services (Tucson, USA) and co-national principal investigator. “The ability to endovascularly profuse the left subclavian artery plays a key role in minimising surgical procedures and related risks.”
In the pivotal study, 238 patients were enrolled across multiple aortic pathologies, including aneurysm, dissection, traumatic transection and other isolated lesions. All subjects were enrolled with a technical success rate of 95.8%, reintervention rate of 2.9% through 12 months and disabling stroke rate of 1.7% through 30 days.
“The results of this study, which importantly measured both device technical success and the absence of select adverse events in zone 2 subjects, were very encouraging for a variety of patients across aortic pathologies,” said Himanshu Patel, section head of adult cardiac surgery at the University of Michigan Frankel Cardiovascular Center (Ann Arbor, USA) and co-national principal investigator.
“As the first flexible, off-the-shelf single branch thoracic endoprosthesis for the aortic arch, the TBE device combines the proven conformability and durability of the conformable Gore Tag device with the ability to endovascularly profuse the left subclavian artery,” said Eric Zacharias, Medical Products Division Leader at Gore. “This approval is another step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market.”
The company claims that the Gore Tag thoracic branch endoprosthesis was the first off-the-shelf aortic branch device to participate in a pivotal study and builds on more than 20 years of Gore experience in thoracic aorta innovation. TBE was designed with a pre-cannulated delivery system to improve ease of implantation and minimise the risk of branch vessel coverage, a press release details.