THE OVATION ABDOMINAL STENT GRAFT PLATFORM
TriVascular has pioneered numerous design and manufacturing technologies in pursuit of our commitment to providing optimal solutions for endovascular repair (EVAR). The Ovation® Abdominal Stent Graft Platform is made of metal stents and fabric and utilizes sealing rings to ensure the stent graft is tight against the aorta. Through its less invasive design, Ovation expands the pool of patients eligible for EVAR*.
*RISKS AND BENEFITS Endovascular repair of abdominal aortic aneurysms (AAA) is intended for patients that meet the indications statement in the product instructions for use. Risks and benefits are associated with endovascular repair and open surgical repair. Patients should talk with their doctors about whether they are candidates for endovascular repair and which treatment option is best for them.
Treatment with the TriVascular endovascular stent graft may not be recommended if you cannot have regular follow-up imaging and/or have bleeding disorders, have kidney disease, cannot use blood thinners or cannot tolerate imaging dyes. If you have poor kidney function, you should ask your doctor about the dyes used in some of the imaging studies as they may further decrease kidney function.
It is important to tell your doctor about any condition that could create an infection to the stent graft, if you have any sensitivities or allergies, or if you have had a stroke within 6 months of the operation. As with any medical procedure, endovascular repair involves risks of complications. In the clinical studies, a small number of patients experienced complications including heart attack, kidney failure, significant blood loss, death (for any reason), breathing problems or failure (respiratory failure), and/or decreased blood flow to the intestine.
If you have endovascular repair of your AAA, it is very important that you attend regularly scheduled follow-up appointments with your doctor. Your doctor needs to find out if your stent graft is working right. If you don’t attend these follow up visits, your doctor won’t know if your blood is leaking from your stent graft, if your aneurysm is growing, or if your stent graft has moved (migrated). Only your doctor can tell if you have these problems or other serious problems. If not treated, any of these problems could cause serious harm or death.
In between follow up visits to check the endovascular stent graft, call your doctor immediately or visit the nearest emergency room if you experience any of the following symptoms: pain, numbness, or weakness in the legs, back, chest, or abdomen; discoloration or coldness in the leg; dizziness; fainting; rapid heartbeat; sudden weakness. If you don’t seek medical attention for these symptoms, they could cause serious harm or death.