IDEV Technologies, Incorporated (IDEV), an innovative leader in the development and commercialization of minimally invasive medical technologies, today announced the first procedure in the United States utilising the Supera Veritas Transhepatic Biliary System, which was recently cleared to market by the USA Food and Drug Administration.
The Supera Veritas wire interwoven nitinol stent is currently cleared in the USA for palliative treatment of biliary strictures produced by malignant neoplasms. Biliary strictures involve a narrowing of the bile duct, the body’s transportation system for fluid that is an essential aid to the digestion of food. Stents are commonly used to re-open the bile duct and restore the natural flow of fluids.
Mark Garcia, chief of Interventional Radiology at Christiana Care Health System in Newark, Delaware, is the first physician in the USA to treat a patient’s biliary stricture with the new Supera Veritas system. “The Supera’s high radial strength is uniquely suited for treating biliary strictures. Because of its characteristics, I have deployed a number of Supera stents over the past year. This new delivery system worked flawlessly. The driving mechanism was smooth and very responsive. The post-procedure images revealed optimal stent placement with excellent cholangiographic results and patency. I am very pleased with the result.”
“We are thrilled to get positive feedback on the initial deployment of the Supera Veritas system in the USA,” said Christopher M Owens, president and CEO of IDEV. “The US experience mirrors that of our customers in Europe and Canada, where the Supera Veritas system has been in use for the past year. The stent’s radial strength and flexibility combine to produce extremely high fracture resistance, and may redefine how patients are treated.”
Full commercial launch of the Supera Veritas Transhepatic Biliary System is planned for the first quarter of 2011.