TriVascular Inc. landed U.S. humanitarian device exemption approval for its Ovation abdominal stent graft system used to repair abdominal aneurysms.
The 20 mm Ovation system was approved by the FDA on Nov. 1 for use in patients with small iliac or femoral artery access of less than 7 millimeters.
The federal watchdog agency’s report said that TriVascular’s system was not only small, but it uses a narrower delivery system than any other marketed endograft, 4.7 millimeters in diameter compared to 7 millimeters in typical catheters.
"The design and available sizing of the Ovation Abdominal Stent Graft are well suited to treat patients with small aortic anatomy who are currently left without less invasive treatment options," Michael Dake, professor of cardiothoracic surgery at Stanford University Hospital said in prepared remarks.
The Santa Rosa, Calif.-based company’s stent graft system was launched commercially in Europe in January and enrollment in the continued access study in the U.S. is ongoing.
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