Ovation Prime is a stent-graft platform designed to address limitations associated with conventional EVAR devices, allowing devices to be customized to the unique anatomy of a patient to effectively seal an aneurysm. To date, some 5,000 patients worldwide have been treated using the system, according to a press release.
The Ovation Prime system is designed to allow surgeons to create a customized seal by filling conformable O-rings with the CustomSeal polymer.
Earlier this year, the company received CE Mark clearance on CustomSeal. More than 250 procedures have been performed in Europe using the polymer, according to the release.
"We are committed to rapidly delivering innovation that addresses relevant unmet clinical needs," CEO Christopher Chavez said in prepared remarks. "The approval of the CustomSeal Technology is part of a strong cadence of product innovations designed to expand EVAR access to more patients and improve EVAR for all patients."
TriVascular revenue rose more than 60% in the 2nd quarter from a year earlier to $7.8 million, with the company reporting a $14.6 million loss for the period. The company netted $81 million in an April initial public offering of stock.
In September, TriVascular said it initiated a field-safety corrective action related to about 30 of its 29mm Ovation Prime grafts, after complaints related to incomplete polymer fill during implantation, possibly leading to transient hypotension, prolonged procedure time, or failure to exclude the aneurysm.