GORE® VIABAHN®
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Patient Information

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This brochure has been provided as a courtesy from Gore & Associates. It is designed to provide helpful information about risk factors and common symptoms associated with peripheral vascular disease. Additionally, it provides information about a new, minimally-invasive method for treating it. We hope this information will be helpful to you and your family.

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Introduction In the U.S. alone, approximately 8-12 million people suffer from some form of peripheral vascular disease (PVD). Peripheral vascular disease is caused by the buildup of plaque inside the arteries in the lower limbs, resulting in decreased blood ow. This brochure describes peripheral vascular disease and some of the available treatment options. One new treatment option is endovascular repair using an endovascular graft. For your convenience, we have included a Glossary of Medical Terms on page 18 and space in this brochure on page 21 to jot down questions to discuss with your...

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Peripheral artery Plaque Atherosclerosis — the build-up of plaque and fatty substances in the artery over time. Figure 1

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What is Peripheral Vascular Disease? Vascular disease involves the buildup of plaque and fatty substances on the inner lining of arteries, a process called atherosclerosis (see Figure 1). This process commonly occurs in arteries throughout the body over time. The presence of atherosclerosis in peripheral arteries is usually referred to as peripheral vascular disease. The term stenosis describes a lesion in the artery in which blood ow is partially blocked; a lesion in which the artery is completely blocked is called an occlusion. The most common locations of PVD (peripheral vascular...

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What Are Some of the Symptoms of Peripheral Vascular Disease? Many people do not experience any symptoms of peripheral vascular disease (PVD). In many of these cases, treatment is unnecessary. However, as symptoms increase in severity, action may be required. Depending on the location of the disease, one or more of the following symptoms may be present: Claudication (dull pain in the buttocks, thighs, calves, or feet following exercise or walking) Numbness or tingling in the leg, foot, or toes Changes in skin color (i.e., paleness or a bluish color) in the leg, foot, or toes Absence of a...

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What Causes Peripheral Vascular Disease? Over time, the accumulation of fatty substances on the vessel wall, combined with inammation of the vessel wall, limits blood ow. When the blood ow becomes severely limited, the muscles surrounding the artery do not receive enough oxygen, and you feel pain. The cause of this process is not completely understood, but many factors have been identied that increase the likelihood of PVD. Risk factors for developing PVD include: heredity (family history) smoking diabetes heart disease obesity high blood pressure high cholesterol Most doctors will advise...

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How Do Doctors Treat Peripheral Vascular Disease? The amount and location of the peripheral vascular disease, and your general health, will determine how you should be treated. When the symptoms are mild, your doctor may only recommend periodic check-ups. However, more serious symptoms may require treatment. Several options are available if your doctor feels treatment is necessary: Risk Factor Modication: Before performing a procedure, your doctor may recommend changes in your lifestyle to treat your PVD, including decreasing the amount of fat and cholesterol in your diet, stopping smoking,...

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Artist’s rendition of the GORE VIABAHN® Endoprosthesis in the supercial femoral artery Plaque ePTFE graft Figure 3 Nitinol stent Photograph of several sizes of the GORE VIABAHN® Endoprosthesis

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What is the GORE VIABAHN® Endoprosthesis? The GORE VIABAHN® Endoprosthesis is a very thin vascular graft that is supported by a metallic support structure known as a stent. The graft is made from uoropolymer (expanded polytetrauoroethylene or “ePTFE” and uorinated ethylene propylene or “FEP”) materials, which have been used safely in vascular grafts for 30 years. The stent is made of a exible, high-strength metal called Nitinol (see Figures 2 and 3). Prior to implantation, the endoprosthesis is compressed on the end of a long, thin, tube-like device called a delivery catheter (see Figure...

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GORE VIABAHN® Endoprosthesis An angiogram showing a section of the supercial femoral artery blocked with plaque. An angiogram with blood owing through a GORE VIABAHN® Endoprosthesis in the supercial femoral artery.

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How is the GORE VIABAHN® Endoprosthesis Implanted? To treat your vascular disease, the GORE VIABAHN® Endoprosthesis is placed inside the blood vessel to create a new, disease-free channel for blood ow. The endovascular graft is implanted using uoroscopy (real-time X-ray images) viewed on a TV monitor in these simple steps: 1. A delivery catheter is inserted into the femoral artery and carefully guided through the leg artery to the site of the blockage. 2. Once the delivery catheter reaches the diseased area, the endovascular graft is released from the delivery catheter. 3. The device...

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What Are the Risks of the GORE VIABAHN® Endoprosthesis? Implantation of a GORE VIABAHN® Endoprosthesis may cause complications at the insertion site artery, or in the leg artery it is intended to treat. Complications that are related to the device may include but are not limited to: Hematoma (bruise) Stenosis (narrowing of the device) Thrombosis (blood clot in the artery or device) Occlusion (complete blockage of the blood owing in the artery or device) Distal embolism (blood clot in the artery that has traveled down to the arteries in the lower leg or foot) Vessel wall trauma and/or...

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What Follow-Up Examinations Should I Have? Your physician will schedule regular follow-up visits to check on the implanted device, such as at 1, 6, or 12 months following implantation, and then once a year thereafter. It is important that you go to all follow-up visits recommended by your doctor. During these visits, if the physician feels that there is a problem with the endovascuar graft or that the disease has spread to other locations in your arteries, additional tests may be conducted. When Should I Call My Doctor? The long-term safety and effectiveness of endovascular repair have not...

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