Data shows 100% successful deployment and no fractures at 30-day follow-up in European Registry
FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) announces the first U.S. implant of the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System. The successful procedure was performed by William Jordan, M.D., chief of the Division of Vascular Surgery and Bradley Leshnower, M.D., cardiothoracic surgeon, at the Emory University School of Medicine in Atlanta on Friday, June 21. This first case follows the recent FDA approval for this new device.
The GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System delivers new levels of control in the endovascular repair of aneurysms, transections, and Type B dissections of the thoracic aorta. A key feature of this device is a delivery system which provides controlled, two-stage deployment, with primary deployment to an intermediate diameter and a secondary deployment to full diameter. In addition to the staged deployment, a lockwire keeps the stent graft attached to the catheter through the procedure, enhancing the physician’s control. The device also features a full 2 French reduction in profile over previous designs across 10 device sizes.
“The two-stage deployment provided by the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System allows for continuous blood flow, and it gives me multiple opportunities to visualize and refine graft placement for accurate placement and peace of mind,” said Dr. Jordan. “The new delivery system gives me added precision in placement and angulation so I can take full advantage of the conformability of the Gore device and confidently provide a minimally-invasive solution to more patients, even in patients with complex anatomy.”
The GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL received CE Mark in 2017. At 30-day follow-up, the device demonstrated 100% successful deployment and zero type IA or type III endoleaks, fractures, device compressions or ruptures, according to real-world data from the post-market European observational, single-arm SURPASS registry. No device-related issues were reported by 98.4% of registry participants, and 97.2% of registry subjects were reported free from serious access complications. Further, 98.4% of registry participants reported improved proximal wall apposition at procedural completion, and 92.9% reported no rapid pacing was used.
“Gore has continuously partnered with physicians to innovate and evolve our stent graft offerings to deliver better long-term patient care,” said Eric Zacharias, vascular business leader at Gore. “We engineered this device with the goal of overcoming known TEVAR limitations related to control and accuracy during deployment. With this new milestone, Gore continues its commitment to developing solutions that advance the treatment of endovascular aortic disease.”
The GORE TAG Conformable Thoracic 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 portfolio of products includes the GORE® EXCLUDER® AAA Endoprosthesis for the treatment of abdominal aortic aneurysms (AAA). The GORE® EXCLUDER® Iliac Branch Endoprosthesis is the first FDA-approved, off-the-shelf device for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms, and is intended for use with the GORE® EXCLUDER® AAA Endoprosthesis.
* For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).
MEDICAL PRODUCTS DIVISIONS
Gore engineers devices that treat a range of cardiovascular and other health conditions. With more than 45 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
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 global recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs 9,500 Associates and generates annual revenues of $3.5 billion. www.gore.com
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Liz DeForest, 212-584-5477