GORE VIABAHN Endoprosthesis Marks 20 Years of Proven Performance

W. L. Gore & Associates Inc. (Gore) is celebrating the 20th anniversary of the introduction of the GORE VIABAHN Endoprosthesis, the stent-graft for the treatment of complex peripheral vascular disease. The device has been engineered to effectively cover and seal off diseased tissue, providing an endoluminal bypass option for physicians faced with complex, challenging lesions. Since the first implant in Europe in 1996, the device formerly known as the GORE HEMOBAHN Endoprosthesis has continuously evolved, now offering CBAS Heparin Surface, lengths up to 25 cm, radiopaque markers, a low profile design, and multiple indications for use. The GORE VIABAHN Endoprosthesis is backed by an ever-growing body of clinical data, including nine randomized or prospective multicenter studies. This continued device evolution and extensive body of clinical proof have enabled the GORE VIABAHN Endoprosthesis to become many physicians’ go-to device for their most challenging cases, selling more than 700,000 units worldwide since its launch.
 
“The original introduction of the GORE VIABAHN Endoprosthesis as the first SFA stent-graft with proven patency demonstrated the potential of endoluminal bypass. Since then, the expanded clinical indications for use and product improvements have helped me to achieve positive results in patients with complex disease where often, no other therapy is appropriate and able to achieve good clinical long-term results,” said Prof. Johannes Lammer, MD, former Director of Cardiovascular and Interventional Radiology, AKH – Wien, Medical University Vienna, Vienna, Austria, one of the earliest users of the device.
 
The GORE VIABAHN Endoprosthesis is the only stent or stent-graft to receive U.S. Food and Drug Administration approval for use in the superficial femoral artery (SFA) (including de novo or restenotic lesions and in-stent restenosis of bare metal stents), iliac artery, and arteriovenous (AV) access. The GORE VIABAHN Endoprosthesis portfolio spans a wide variety of sizes, including the recently added 7.5 cm and 25 cm length versions, the industry’s longest such device. The dynamic range of options allows physicians to effectively cover complex lesions in the most challenging clinical situations.
 
“In the ever-evolving field of interventional medicine, we can’t rely as much on rule-of-thumb and past experiences. Clinical practice is continually refined as new device and procedure options are introduced to the market. We need rigorous clinical trials to gauge the efficacy of devices in a real-world patient population. Throughout the years, Gore has continued to evaluate the GORE VIABAHN Endoprosthesis in challenging, real-world cases, such as long lesions, AV access outflow stenosis, and in-stent restenosis in the SFA, progressing our treatment options in these very complex cases,” said Richard R. Saxon, MD, FSIR, Director of Research, SDCVI, San Diego Imaging Medical Group, San Diego, Calif.
 
Later this month, in conjunction with the Vascular Interventional Advances 2016 (VIVA) Conference in Las Vegas, Gore will release new data from the most recent clinical study on the device’s performance in treating long, complex lesions in the SFA. Prof. Takao Ohki, MD, PhD, of the Jikei University School of Medicine in Tokyo, Japan, will be presenting 12-month results from the GORE VIABAHN Endoprosthesis Japanese Investigational Device Exemption (IDE) Clinical Study on Tuesday, September 20, at a sponsored breakfast symposium. More information about the GORE VIABAHN Endoprosthesis and the study results to be presented at VIVA 2016 can be found here.
 
“During the last two decades, we have seen stent-grafts progress to become a primary treatment option for complex peripheral vascular disease. From the introduction of the endoluminal bypass to the market in 1996, Gore has worked in partnership with the endovascular community to innovate, developing smaller profiles, a thromboresistant surface, and new lengths and diameters, all of which help improve patient outcomes,” said Ray Swinney, Peripheral Interventional Business Unit Leader at Gore.
 
The GORE VIABAHN Endoprosthesis is constructed with a biocompatible, durable, reinforced, expanded polytetrafluoroethylene (ePTFE) liner. Its flexible design enables the device to traverse tortuous anatomies and provide durable outcomes in complex disease. The device is also available with CBAS Heparin Surface, the proven, lasting heparin bonding technology designed to resist thrombus formation.