US medical device company TriVascular has commenced the US Post-Approval Study (PAS) of the Ovation Prime Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA).
The Ovation System and the Ovation Prime System has secured Premarket Approval (PMA) and are marketed throughout Europe.
PAS national principal investigator Dr. Syed Hussain said the Ovation device will treat AAA patients who otherwise would not have been candidates for EVAR therapy.
"In our clinical experience, we have found the Ovation stent graft’s low profile and unique O-ring sealing technology to be highly effective in treating both straightforward and challenging anatomies," added Hussain.
Ovation System has added capabilities, which expands EVAR usage to a broader AAA patient population including those with narrow access arteries, short aortic necks and other challenging anatomies.
TriVascular Chairman, CEO and president Christopher G Chavez said, "We believe aneurysm access advantages enabled by our low profile system, combined with our unique O-Ring sealing technology will enable physicians to offer this clinically proven minimally invasive therapy to a significant number of patients previously not considered candidates for EVAR."
TriVascular is a subsidiary of TV2 Holding. It develops advanced products for the treatment of cardiovascular disease.
The company offers endovascular solutions for patients with aortic aneurysmal disease. Its products include abdominal stent graft systems for the treatment of abdominal aortic aneurysms, and thoracic stent graft systems for the treatment of the thoracic aorta.