CustomSeal technology for the Ovation Prime System gets FDA approval


TriVascular announced on 15 October 2014 that the FDA has approved the CustomSeal technology for the Ovation Prime System. With the Ovation Prime endograft system, physicians create a customised seal by filling the conformable O-rings with the CustomSeal polymer, effectively completing the last step of the manufacturing process in vivo.

The CustomSeal technology was designed with the same biocompatible components as the Ovation Prime polymer, but now enables faster procedure times through a 30% reduction in cure time. The first cases with the new sealing technology were completed by Stuart A Harlin, president, Coastal Vascular and Interventional PLLC in Pensacola, USA, and Zvonimir Krajcer, co-director, Peripheral Vascular Disease Service at Texas Heart Institute in Houston, USA.

“I was impressed with the performance of the CustomSeal Technology,” commented Harlin. “The decrease in the polymer time provides an opportunity for reduced operative time and anaesthesia exposure for our patients. Furthermore, the ability to offer our patients a customised and truly minimally invasive endovascular solution is of great value to our practice.”

“We are committed to rapidly delivering innovation that addresses relevant unmet clinical needs,” said Christopher G Chavez, chairman, CEO and president of TriVascular. “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.”

The Ovation platform has been used in the successful treatment of approximately 5,000 patients worldwide. Excellent clinical results have been reported from both the Ovation global pivotal trial and a 501-patient European post-market registry. Earlier this year, the CustomSeal technology received CE mark clearance and over 250 cases have been performed with the CustomSeal polymer in Europe. The Ovation Prime system is available for sale in over 25 countries around the world.