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FDA approves system to repair abdominal aneurysms in those with small arteries

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The FDA and TriVascular announced approval of a stent graft system that provides those with small arteries the option of less-invasive surgery to repair abdominal aortic aneurysms.

According to the company, the device (Ovation Abdominal Stent Graft System, TriVascular) is the first Humanitarian Device Exemption granted by the FDA in the field of abdominal aortic aneurysm treatment. With this approval, patients previously ineligible for endovascular aneurysm repair will gain access to a minimally invasive therapy.

“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 D. Dake, MD, professor of cardiothoracic surgery and medical director, Catheterization and Angiography Laboratories, Stanford University Hospital, said in the company press release. “Coupled with Ovation’s extremely low profile, 14F OD delivery system, this Humanitarian Use Device will expand treatment options for patient groups currently served endovascular aneurysm repair, such as women.”

Under the Humanitarian Device Exemption, the system is approved for use in patients with access vessels of less than 7 mm in diameter and aortic necks with lengths of at least 7 mm and diameters between 15.5 mm and 17.4 mm. The system is contraindicated in patients with an infection that threatens to infect the graft, in patients who have allergies to the device materials and in patients who are unable to undergo the necessary preoperative and postoperative imaging studies.

The 20-mm stent graft system was approved by the FDA on Nov. 1. According to the company, it differs from traditional endografts because 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 to expand the endograft against the aorta to create a seal.

The stent graft system was launched commercially in Europe in January. In the US, the pivotal study completed enrollment in March. Enrollment in a continued access study is ongoing.

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