Gore is celebrating the 20th anniversary of the introduction of the Viabahn endoprosthesis; its stent graft for the treatment of complex peripheral vascular disease. Gore says that 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 Hemobahn endoprosthesis has evolved to offer CBAS heparin surface, lengths up to 25cm, radiopaque markers, a low-profile design, and multiple indications for use. The Viabahn is backed by a body of clinical data that includes nine randomised or prospective multicentre studies. More than 700,000 units have been sold worldwide since its launch.
“The original introduction of the Gore Viabahn endoprosthesis as the first superficial femoral artery 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 Johannes Lammer, former director of Cardiovascular and Interventional Radiology, AKH-Wien, Medical University Vienna, Vienna, Austria, one of the earliest users of the device.
Gore says that the Viabahn is the only stent or stent graft to receive US Food and Drug Administration approval for use in the superficial femoral artery (including de novo or restenotic lesions and in-stent restenosis of bare metal stents), iliac artery, and arteriovenous (AV) access. The Viabahn portfolio spans a wide variety of sizes, including the recently added 7.5cm and 25cm length versions, the industry’s longest such device, which allows physicians to cover complex lesions.
“In the ever-evolving field of interventional medicine, we cannot 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 Viabahn endoprosthesis in challenging, real-world cases, such as long lesions, AV access outflow stenosis, and in-stent restenosis in the superficial femoral artery, progressing our treatment options in these very complex cases,” said Richard R Saxon, director of Research, SDCVI, San Diego Imaging Medical Group, San Diego, USA.
Later this month, in conjunction with the Vascular Interventional Advances 2016 (VIVA) Conference (18–22 September, Las Vegas, USA), Gore will release new data from the most recent clinical study on the device’s performance in treating long, complex lesions in the superficial femoral artery. Takao Ohki, 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 clinical study on 20 September at a sponsored breakfast symposium.