November 2, 2011 — A new stent graft system approved by the US Food and Drug Administration (FDA) yesterday solves a human plumbing problem that makes it harder to treat patients with an abdominal aortic aneurysm.
If a patient's arteries are too small, physicians cannot slip in a typical stent graft, or endograft, with a catheter to reinforce a bulging and weakened stretch of aorta in the abdomen. They instead must resort to more invasive open surgery to repair the artery.
The Ovation Abdominal Stent Graft System, approved by the FDA yesterday, gives patients with small arteries the option for less invasive surgery. The endograft is not only small in diameter (20 mm) but is also compressed into a delivery catheter only 4.7 mm in diameter, far narrower than those on the market.
The new stent graft system, manufactured by TriVascular, is indicated for 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. It is contraindicated for patients with an infection that could spread to the graft and those with allergies to materials in the device. Physicians should not install the stent graft in patients who are unable to undergo the prerequisite preoperative and postoperative imaging studies.
The FDA approved the stent graft system as a humanitarian use device, a classification for products that treat or diagnose fewer than 4000 people in the country each year. The agency determined that the device is safe and that its probable benefits outweigh the risk for injury or illness after reviewing clinical data from a 4-participant study as well from a study of an earlier version of the product. Serious adverse events included cardiac events and problems pertaining to the circulatory, lymphatic, pulmonary, digestive, and genitourinary systems. The adverse events were consistent with those of other endovascular grafts.
More information about yesterday's announcement is available on the FDA's Web site.
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Cite this: Aneurysm Stent Okayed for Patients With Small Arteries - Medscape - Nov 02, 2011.