Gore Receives FDA Approval For GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface
Flagstaff, AZ - W. L. Gore & Associates (Gore) recently announced that it has received approval from the US Food & Drug Administration (FDA) to market its GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface for vascular bypass in the Superficial Femoral Artery (SFA). The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface combines Gore's proprietary heparin surface treatment with the proven performance of the GORE VIABAHN Endoprosthesis for treatment of Peripheral Vascular Disease (PVD) in the SFA. In the US alone, as many as 12 million people suffer from some form of PVD.
The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is a stent-graft and the only device of its kind on the market approved for treating the SFA. The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface uses end-point covalent bonding to keep the heparin anchored to the endoprosthesis surface over time. The proprietary end-point surface attachment technology preserves the heparin bioactive sites such that they remain free to interact with the blood without being consumed.
According to Gary Ansel, MD, interventional cardiologist at MidOhio Cardiology and Vascular Consultants and Riverside Methodist Hospital, "Clinical data has confirmed the success and safety of the GORE VIABAHN® Endoprosthesis for use as an endoluminal bypass. The addition of the heparin-bonded ePTFE component is the first of its kind for the SFA and an exciting advancement that we are anxious to apply in our practice." Dr. Ansel performed the nation's first implant of the newly-approved device and is a principal investigator for the VIBRANT (GORE VIABAHN Endoprosthesis veRsus bAre Nitinol stenT) Study of comparative treatments for Peripheral Arterial Disease (PAD) of the SFA.
"Gore is excited to bring this heparin-bonded technology to the GORE VIABAHN® Endoprosthesis. This gives us the unique position of being the only stent-graft approved for the SFA and now providing a heparin-bonded surface," said Ben Beckstead, PhD, product specialist at Gore.
GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (5 to 8 mm devices) is available with a new, lower-profile delivery system that gives interventionalists a more streamlined approach to re-line the SFA with a smooth ePTFE lumen supported by a highly flexible stent scaffold. The GORE VIABAHN Endoprosthesis is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The excellent flexibility of the GORE VIABAHN Endoprosthesis enables it to better traverse tortuous areas of the SFA and conform more closely to the complex anatomy of the artery.
About W. L. Gore & Associates
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery. Gore was recently named the tenth best company to work for by Fortune magazine.
Products listed may not be available in all markets pending regulatory clearance. GORE, VIABAHN and design are trademarks of W. L. Gore & Associates.
SOURCE: W. L. Gore & Associates