November 30, 2012 — TriVascular Inc. announced premarket approval (PMA) of the Ovation Abdominal Stent Graft System by the U.S. Food and Drug Administration (FDA) for the treatment of abdominal aortic aneurysms (AAA). Delivered through a 14 French (4.7 mm) outer diameter catheter, Ovation is the lowest profile commercially available system for EVAR. With a broader set of indications for use (IFU) than other approved systems, Ovation expands the pool of patients eligible for EVAR.
The Ovation Abdominal Stent Graft System is used instead of a more open (invasive) surgery in patients who have an abdominal aortic aneurysm. The stent system should benefit patients with an abdominal aneurysm by redirecting blood flow, preventing growth or rupture of the aneurysm.
The Ovation Abdominal Stent Graft System should not be used in patients who:
- Are unable to undergo the necessary preoperative and postoperative imaging and implantation studies;
- Have an infection that might threaten to infect the stent graft; and
- Are sensitive to, or allergic to, the device materials.
The Ovation Abdominal Stent Graft System received CE mark approval in August 2010. In the United States, Ovation received the first-ever humanitarian device exemption (HDE) approval for EVAR in November 2011. To date, more than 1,000 patients worldwide have been successfully treated with the Ovation Abdominal Stent Graft System.
TriVascular is directly marketing Ovation in select European countries while actively appointing independent distributors in other international markets. With PMA approval in hand, TriVascular plans to build a direct field service organization domestically to drive patient access to Ovation in the United States.
For more information: www.trivascular.com