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US FDA Grants Approval To Gore’s Next Generation GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface

W. L. Gore & Associates has received FDA approval to market the GORE VIABAHN Endoprosthesis for device diameters 9 – 13 mm in the US. The product enables streamlined deployment on the same 0.035” guidewire and TIP to HUB direction as the 5 – 8 mm sizes. Additional modifications to the product include radial device expansion, a contoured proximal edge and a lower profile that is available for most sizes.

“The self-expanding, covered, GORE VIABAHN Endoprosthesis offers elegant and versatile endovascular solutions to difficult vascular problems,” said Michael B. Silva, Jr., MD, Professor of Vascular Surgery, Professor of Radiology and Director of the Texas Vascular Center, University of Texas Medical Branch. “The latest improvements to the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, including smaller delivery profile and 0.035” wire compatibility for the larger diameter endografts, will allow us to easily deliver the larger devices to more locations. Treating difficult vascular problems requires good skills and good equipment. We just got some cool new enhancements to our toys.”

The GORE VIABAHN Endoprosthesis portfolio of devices are constructed with a reinforced, durable, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. GORE VIABAHN Endoprosthesis is highly flexibile. Its flexibility enables it to traverse tortuous areas and to conform to the complex anatomy of the artery.

“The recent modifications to the GORE VIABAHN Endoprosthesis device underscores our commitment to continually provide our customers with next-generation, innovative products for the treatment of Peripheral Arterial Disease (PAD) in the iliac artery,” said Erin Hutchinson with the Gore Peripheral Vascular Business. “Gore strives to be at the forefront of technology innovation and we’re pleased to provide interventionalists with an improved version of the large diameter devices that will allow more patients to receive safe and effective interventional therapies for the treatment of PAD in iliac arteries.”

In 2005, FDA has approved the original device configuration in 6 – 8 mm sizes for treating PAD in the superficial femoral artery (SFA). The company added a 5 mm size and made modifications to the device which include reducing its profile and adding a Heparin Bioactive Surface in 2007. Gore received approval for large diameters of the GORE VIABAHN Endoprosthesis 9 – 13 mm for the indication of improving blood flow in patients with symptomatic peripheral artery disease in iliac artery lesions in 2008. The company announced that the FDA approved a manufacturing change to the device so as to remove excess material at the device margin, resulting in a contoured edge at the proximal end last month. The device is the only stent-graft approved by for the treatment of patients suffering from PAD in superficial femoral and iliac artery lesions.