Abdominal Stent-Graft with NaviterDelivery System Patient Information Brochure Abdominal Aortic Aneurysms Bolton Medica

his brochure is provided by Bolton Medical to offer you information about the Abdominal Stent Grafting repair and the Treovance® Stent-Graft System to treat your abdominal aortic aneurysm. Please read this information and discuss any questions you may have with your doctor. “An Abdominal Aortic Aneurysm is an abnormal swelling or bulge in your abdominal aorta.” Abdominal Aortic Aneurysm What Is an Abdominal Aortic Aneurysm or AAA? An Abdominal Aortic Aneurysm or AAA is an abnormal swelling or bulge in your abdominal aorta. The aorta is your body’s largest artery and carries oxygen-filled blood...

What Causes an Abdominal Aortic Aneurysm? Abdominal aortic aneurysms are most often caused by a weakening in the aorta, resulting from vascular disease, traumatic injury or a genetic defect. In addition, as you age, continuous high blood pressure can cause the aorta to bulge out, thin and weaken, resulting in an aneurysm. Those primarily at risk are men over 60, smokers, and those with a family history. Your risk for an abdominal aortic aneurysm increases if you: • Have high blood pressure • Have a family history of cardiovascular or .. ,. , , , , peripheral vascular disease (a narrowinq of •...

TREATMENT How Is an Abdominal Aortic Aneurysm Treated? Treatment for an abdominal aneurysm depends on its size, location and your overall health. If your doctor feels the aneurysm is at risk to burst or rupture, the treatment is generally either open surgery or endovascular surgery, a newer and less invasive treatment. Conventional Open Surgery In conventional or open surgery, the surgeon reaches the aneurysm through a large incision in the abdomen. The weakened section of the vessel, where the aneurysm has formed, is usually surgically removed and replaced with a synthetic material. Open surgery...

The Bolton Difference Abdominal Stent-Grafting with the Treovance® Stent-Graft Endovascular Abdominal Stent-Grafting is a treatment modality invented in the early 1990s by vascular surgeons as a less invasive endovascular method of repair of an abdominal aortic aneurysm (AAA) and has rapidly expand as a treatment of choice due to its clinical benefits. Now Bolton Medical is offering an updated an improved device for the abdominal stent-graft repair. The Treovance® Abdominal Stent-Graft is a woven fabric tube supported by a tubular metal scaffold. The device is placed inside the diseased abdominal...

The Recovery What Should I Expect After the Procedure? Immediately after the procedure, your doctor may ask you to lay flat for several hours, allowing the healing process to begin. Once you start getting up and around, any pain or swelling you experience should begin to decrease and you should be released from the hospital within a few days. Your doctor will discuss your follow-up plan, which will probably include check-ups at one month, six months, twelve months, and annually thereafter “ENDOVASCULAR ABDOMINAL STENT-GRAFTING IS A TREATMENT MODALITY THAT INVENTED IN THE EARLY 1990s AND HAS RAPIDLY...

PARTICIPANTS Who Can Participate in the Treovance® Stent-Graft Clinical Trial? Main Criteria for Inclusion You may be considered for the Bolton AAA trial if you are: 1. Between the ages of 18 and 85 3. Willing and able to comply with 1-month, 6-month, and 12-month follow-up visits. 2. Diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement, by CT with contrast performed within 3 months of planned implant procedure. Main Criteria for Exclusion Subjects may not enroll into the study if any of the following apply: 1. Subject has a ruptured or symptomatic...

Abdominal Stent-Graft with Navitel Delivery System THE TREOVANCE® ABDOMINAL STENT-GRAFT Manufacturer: Bolton Medical Espana S.L.U. C/Newton, 1 8-24, 08635 Sant Esteve Sesrovires, Barcelona, Spain +34-93-817-63-00 Exclusively for Clinical Investigations. CAUTION - Limited by U.S. Law to investigational use Other Premises: Bolton Med ical, Inc. 799 International Parkway, Sunrise, FL 33325 +1 -954-838-9699. Bolton Medico