FLAGSTAFF, Ariz. – October 20, 2017 – W. L. Gore & Associates, Inc. (Gore) today announced the first patient enrollment in its post-market European registry for the GORE®TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System, following its recent European launch in July 2017. 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 first patient procedure in the registry was performed by Professor Giovanni Torsello and Doctor Martin Austermann at St. Franziskus Hospital, Münster, Germany. Professor Torsello, Chief of the Department of Vascular Surgery, stated, "The GORE® ACTIVE CONTROL System was easy to use and provided a noticeably enhanced level of control in the placement and angulation of the GORE TAG Conformable Thoracic Stent Graft. Enrolling patients in Gore’s registry will help to determine the short- and long-term benefits of this new device, which we expect could include the reduction of complications that can occur if the stent graft is not placed correctly during the TEVAR procedure. The precise control of this stent graft is an exciting advancement for TEVAR, and we are happy to be of the first physicians to experience it.”
The registry, known as SURPASS, will enroll 125 patients who will be followed for 12 months at up to 20 sites across Europe. Data from the registry will evaluate the real-world efficacy of the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System in the treatment of etiologies of the descending thoracic aorta, including aneurysms, transections, and all Type B dissections. Prof. Torsello will serve as the Global Principal Investigator for the registry.
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 of the stent graft within the body to achieve optimal placement prior to full-diameter expansion. The angulation control capability allows the physician 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 challenging anatomies.
The new product offering features the same time-tested stent graft as the Conformable GORE TAG Device that has demonstrated long-term freedom from device-related reintervention (93.1 percent) and low complication rates (zero migrations, fractures, or compressions).* The device is a unique combination of proprietary ePTFE graft material and a fully supported, nested nitinol stent.
“The Conformable GORE TAG Device is already the most-studied** thoracic endograft available on the market,” said Eric Zacharias, Vascular Business Leader at Gore. “We continue to evolve the product to better meet the needs of patients and the physicians who treat them. High-quality, real-world clinical data will continue to be crucial for us to maintain the trusted quality, safety, and effectiveness of this device.”
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 vascular disease, backed by Gore’s highly rated clinical support teams and educational offerings.† The comprehensive portfolio of products includes the Conformable GORE TAG Thoracic Endoprosthesis for the treatment of thoracic aneurysms, transections, and Type B dissections; 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; the GORE® VIABAHN® Endoprosthesis, the market-leading stent graft for the treatment of complex peripheral vascular disease; and the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, the first FDA approved balloon-expandable stent graft for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation.
For potential additions to Gore’s branched portfolio, investigational 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, while maintaining flow into a single aortic arch branch vessel. Both of these are investigational devices that are not yet approved for commercial sale.
* Consolidated outcomes following 5 years of follow-up in TAG 08-01, TAG 08-02, and TAG 08-03 clinical studies.
** Based on company-sponsored trials and registries shown on clinicaltrials.gov for currently available stent grafts.
† For Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU) and / or goremedical.com.
MEDICAL PRODUCTS DIVISION
Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions. With more than 40 million medical devices implanted over the course of more than 40 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. www.goremedical.com
ABOUT W. L. GORE & ASSOCIATES
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments — from revolutionizing the outerwear industry with GORE-TEX® fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. The company is also known for its strong, team-oriented culture and continued recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs approximately 10,000 Associates and generates annual revenues that exceed $3.5 billion. www.gore.com