FDA approves Ovation Abdominal Stent Graft System (Trivascular) for Abdominal Aortic Aneurysm patients

The FDA has approved the Ovation Abdominal Stent Graft System, from Trivascular, which provides patients with small arteries the option of less invasive surgery to repair their potentially life-threatening Abdominal Aortic Aneurysms. Such aneurysms can be repaired through open surgery or less invasively using a stent graft. However this treatment depends on the patient�s anatomy. A small number of people have blood vessels that are too small in diameter to accommodate typical endograft systems on the market. The Ovation Abdominal Stent Graft System (20 millimeter diameter), not only has a small diameter but it uses a narrower delivery system than any other marketed system - 4.7 mm in diameter compared to 7 mm in diameter for typical delivery catheters. In addition, a portion of the usual metal stent is replaced with ring-shaped channels in TriVascular's device. Once in place in the aorta, the channels are injected with a polymer, expanding the endograft against the aorta to create a seal. The system is approved for use in patients with iliac or femoral artery access of less than 7 mm and an aorta with an inner diameter between 15.5 mm and 17.4 mm.