Gore Announces First Commercial In-Human Use Of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System For TEVAR In Australia

FLAGSTAFF, Ariz. — July 2, 2018 — W. L. Gore & Associates Inc. (Gore) today announced the first patient implant of the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System after being included on the Australian Register of Therapeutic Goods last month in Australia.

The first implants were performed by Professor Ian Spark at Flinders Medical Centre, Adelaide, South Australia.

The thoracic endovascular aortic repair (TEVAR) device is the first to feature a new delivery system that provides the physician with controlled, staged deployment. The system optimizes accuracy, angulation, and apposition to treat etiologies of the descending thoracic aorta including aneurysms, transections, and acute and chronic Type B dissections.

The GORE Active Control System enhances the exceptional conformability of the stent graft; facilitating the optimized wall apposition that the Conformable GORE Tag Device is renowned for even in complex anatomies, such as acute aortic angles. The novel staged deployment feature enables the physician to refine positioning and angulate the stent graft within the body to achieve optimal placement prior to full-diameter expansion. The angulation control capability gives physicians the option to angulate the device to achieve orthogonal placement to the aortic blood flow lumen and maximize conformability and seal. These features enable physicians to more confidently perform endovascular treatment even in anatomies where tortuous vessels might historically have suggested open surgery.

“The Gore Tag Conformable Stent Graft is a reliable and trusted device that I have used for TEVAR procedures with my patients for many years,” Professor Spark comments. “The availability of the new Gore Active Control System is an exciting advancement because it significantly enhances the control I have when deploying the stent graft, making it easier to accommodate challenging anatomies. The angulation and precision deployment capabilities could decrease the risk of common complications and reduce the likelihood for future interventions that result in additional trauma for patients and costs to providers. Both the control in the delivery system and long-term benefits of the stent graft mark significant advancement for the medical community.”

The new product offering features the same time-tested stent graft as the Conformable Gore Tag Device, whose predictable outcomes have been established through its long-term freedom from reintervention (89 percent for aneurysms in the descending thoracic aorta* and 100 percent for traumatic transections**) through five years, and 90 percent dissection-related survival through 1 year***. The device is a unique combination of proprietary ePTFE graft material and a fully supported, nested, nitinol stent.

“Since Gore pioneered the first Tevar device in Europe two decades ago, we have welcomed feedback from our physician partners to innovate and evolve our stent graft offerings for better long-term patient care,” said Eric Zacharias, vascular business leader at Gore. “The Gore Tag Device family has a legacy of trusted performance and durability, and we knew we could build on that by enhancing control during deployment which would help make Tevar procedures more predictable for physicians. Physicians can now deploy our thoracic stent graft in the descending thoracic aorta with more operative ease, even in those patients with extremely angulated aortic arches, and meet the clinical and practical challenges of Tevar with confidence. With this latest product iteration, Gore is continuing its unparalleled commitment to developing solutions that advance endovascular solutions for diseases of the aorta.”

The Gore Tag Conformable Stent Graft with Active Control System is part of the growing family of endovascular products that share a mission to effectively treat aortic disease, backed by Gore’s highly rated clinical support team and educational offerings. The comprehensive portfolio of products includes the Gore EXCLUDER® AAA Endoprosthesis for the treatment of abdominal aortic aneurysms (AAA), as well as the Gore Excluder Iliac Branch Endoprosthesis (IBE), the first FDA approved off-the-shelf device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. For potential additions to Gore’s branched portfolio, studies are ongoing for the Gore Excluder Thoracoabdominal Branch Endoprosthesis (TAMBE), and enrollment continues in the Gore Tag Thoracic Branch Endoprosthesis (TBE) Pivotal Study to assess safety and effectiveness in treating lesions of the aortic arch and descending thoracic aorta.

* TAG08-03 Clinical trial for treatment of aneurysms of the descending thoracic aorta

** TAG08-02 Clinical trial for Traumatic Transections

*** TAG08-01 Clinical trial for Acute Complicated Type B Dissection Clinical Trial

Posted July 3, 2018

Source: W. L. Gore & Associates