A new stent graft system has won FDA approval for repairing abdominal aortic aneurysms in patients with vessels too small for standard endograft products, the agency said Wednesday.

The 20-mm stent graft, sold under the name Ovation and manufactured by TriVascular, is smaller than other endografts currently on the market and can be delivered through a 4.7-mm catheter, according to the FDA.

Other aortic aneurysm endografts require a 7-mm catheter, the agency said.

"FDA's approval of this product will enable some patients with small blood vessels to be treated via minimally-invasive surgery who did not previously have this option," said Christy Foreman, director of the FDA's Office of Device Evaluation, in a statement.

The approval specifies that the device is for 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.

The product is contraindicated in patients with an infection that threatens to infect the graft, and in patients who have allergies to the device materials. It also should not be used in patients who are unable to undergo the necessary preoperative and postoperative imaging studies.

It was approved as a Humanitarian Use Device, on the basis of testing in four individuals that showed reasonable assurance of safety and the probability of favorable benefit-risk balance.

Evaluations conducted periodically for one year after placement indicated no problems with migration, kinking, leakage, or aortic rupture.

The FDA said it also considered long-term efficacy data on a previous version of the Ovation stent.

Serious adverse events were similar to those seen with other endovascular grafts, such as cardiac events and hematologic, gastrointestinal, genitourinary, and pulmonary problems, according to the FDA.

The agency has told the company to collect data on complications and adverse events for five years.

The Ovation product includes ring-shaped channels in part of the stent, into which a polymer is injected after placement. The procedure pushes the stent against the aorta's interior wall to create a seal.
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Source:  MedPage Today