SANTA ROSA -- TriVascular Technologies, Inc. (NASDAQ:TRIV) said Wednesday that the U.S. Food and Drug Administration approved CustomSeal technology for its Ovation Prime System, used in abdominal aortal stent grafts to repair heart disease.
With the Ovation Prime endograft system, physicians make a custom seal by filling O-rings with CustomSeal, a polymer. The CustomSeal technology has the same biocompatible components as TriVascular's Ovation Prime polymer, but allows faster procedures because it reduces cure time by 30 percent. The new sealant also helps preserve the aortic neck, and can be custom tailored to each patient's anatomy.
Early cases using the new sealing technology were done by Stuart Harlin, MD, president, Coastal Vascular and Interventional PLLC in Pensacola, Florida, and Zvonimir Krajcer, MD, at Peripheral Vascular Disease Service, Texas Heart Institute, Houston, Texas.
"I was impressed with the performance of the CustomSeal Technology," said Dr. Harlin. "The decrease in the polymer time provides an opportunity for reduced operative time and anesthesia exposure for our patients. The ability to offer our patients a customized 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 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 to treat about 5,000 patients worldwide. More than 250 cases have been performed with CustomSeal polymer in Europe. The Ovation Prime system is sold in 25 countries around the world.
TriVascular is a medical device company developing technologies for minimally invasive treatment of abdominal aortic aneurysms. The company expects 2014 revenue of $32 million to $36 million, up more than 60 percent over 2013. Gross margin is in the range of 56 percent.
