FDA Approves CustomSeal Technology for TriVascular's Ovation Prime System

October 15, 2014—TriVascular announced that the US Food and Drug Administration has approved its CustomSeal technology for the Ovation Prime endograft system. The customized sealing technology enables faster procedure times, preserves the aortic neck, and provides an optimized seal that is tailored to each patient’s specific anatomy, stated the company.

Earlier this year, CustomSeal technology received European CE Mark approval. The Ovation Prime system is available for sale in over 25 countries around the world.

According to TriVascular, interventionists create a customized seal by filling the conformable O-rings of the Ovation Prime system 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 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, MD, and Zvonimir Krajcer, MD. Dr. Harlin is president of Coastal Vascular and Interventional PLLC in Pensacola, Florida. Dr. Krajcer is codirector of Peripheral Vascular Disease Service at Texas Heart Institute in Houston, Texas.

In TriVascular’s press release, Dr. Harlin commented, “I was impressed with the performance of the CustomSeal technology. The decrease in the polymer time provides an opportunity for reduced operative time and anesthesia exposure for our patients. Furthermore, the ability to offer our patients a customized and truly minimally invasive endovascular solution is of great value to our practice.”