TriVascular Says FDA OKs CustomSeal Technology For Ovation Prime System

(RTTNews) - TriVascular Technologies, Inc. (TRIV) on Wednesday said the U.S. Food and Drug Administration or FDA has approved its CustomSeal Technology for the Ovation Prime System.

Customized sealing technology enable faster procedure times, preserves the aortic neck and offers an optimized seal tailored to each patient's specific anatomy. With the help of ovation prime endograft system, physicians can create a customized seal by filling the conformable O-rings with the CustomSeal polymer, effectively completing the last step of the manufacturing process in vivo.

The Ovation platform has helped in treating nearly 5,000 patients worldwide. Earlier this year, CustomSeal technology had received CE Mark clearance and over 250 cases have been performed with CustomSeal polymer in Europe.