TriVascular Releases Smallest Abdominal Stent Graft System
The Ovation Abdominal Stent Graft System from TriVascular Inc. is for patients with small arteries. It will give them the option of less invasive surgery to repair their potentially life-threatening abdominal aortic aneurysm.
The system is not only small in diameter but it uses a narrower delivery system than any other marketed endograft — 4.7 mm in diameter compared to 7 mm in diameter for typical delivery catheters.
It differs from traditional endografts in that a portion of the metal stent is replaced with ring-shaped channels. After the device is in place in the aorta, the channels are injected with a polymer, expanding the endograft against the aorta to create a seal.
The U.S. Food and Drug Administration (FDA) approved the Ovation system in November 2011 for use in patients with iliac or femoral artery access of fewer than 7 mm and an aorta with an inner diameter between 15.5 mm and 17.4 mm. It was approved as a Humanitarian Use Device (HUD).
For more information: www.fda.gov