Compelo Medical Devices - Latest industry news and analysis is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More
Close
Dismiss

TriVascular obtains FDA approval for CustomSeal Technology for Ovation Prime System

TriVascular Technologies has received approval from the US Food and Drug Administration for its CustomSeal Technology for the Ovation Prime System.

With the Ovation Prime endograft system, physicians will create a customized seal through filling the conformable O-rings with the CustomSeal polymer.

According to the company, the CustomSeal technology has been developed with the same biocompatible components as the Ovation Prime polymer, and allows faster procedure times through a 30% reduction in cure time.

TriVascular president and CEO Christopher Chavez said: "We are committed to rapidly delivering innovation that addresses relevant unmet clinical needs.

"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."

At the starting of this year, the CustomSeal technology obtained CE mark approval. Currently, the Ovation Prime system is available in around 25 countries across the globe.

The company produces Ovation Prime Abdominal Stent Graft System, which is the lowest profile FDA-approved EVAR system.