TriVascular has received a humanitarian device exemption from the FDA for its Ovation abdominal stent graft system for the treatment of abdominal aorta aneurysms. The Ovation has a low profile with a flexible delivery system of just 14 French, which is smaller than any other endovascular aneurysm repair (EVAR) system currently on the market, of which the smallest start at 18 French. It is suitable for patients for whom other EVAR systems are not an option because of a short proximal neck or small access vessels. The Ovation is approved for use in patients with access vessels of less than 7mm in diameter and aortic necks with lengths of at least 7mm and diameters between 15.5mm and 17.4 mm.
The Ovation is anchored only above the aneurysm and has integrated polymer-filled sealing rings, which are expanded upon deployment to exactly conform and seal to the patient’s unique anatomy, excluding the aneurysm. This may be especially advantageous in patients with heavy calcification, highly thrombosed anatomy and reverse-tapered necks.
Press release: TriVascular, Inc. Receives U.S. Humanitarian Device Exemption Approval for the Ovation Abdominal Stent Graft System…
Product page: Trivascular Ovation…
Flashback: TriVascular’s Ovation AAA Stent Gets Green Light in EU