IDEV receives FDA marketing clearance for SUPERA VERITAS Transhepatic Biliary System

Nov 3 2010

IDEV Technologies, Incorporated (IDEV), an innovative leader in the development and commercialization of minimally invasive medical technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance to market the SUPERA VERITAS Transhepatic Biliary System.

SUPERA VERITAS is the next-generation delivery system for IDEV's unique SUPERA® wire interwoven nitinol stent, currently cleared in the U.S. for palliative treatment of biliary strictures produced by malignant neoplasms.  The SUPERA VERITAS system is also approved for use in the ongoing FDA-approved IDE trial in the U.S. for treatment of peripheral arterial disease of the superficial femoral artery (SFA).  The FDA 510(k) clearance notification was dated October 5, 2010.

"Clearance of the SUPERA VERITAS system represents the culmination of a strong effort to respond to customer needs," explained Christopher M. Owens, President and CEO of IDEV.  "The result is an innovative system that we believe provides us with a significant competitive advantage, and may represent a paradigm shift in how patients are treated."

The new device provides easier deployment of the Supera stent compared to earlier systems, eliminating multiple steps previously required for preparation and delivery.  More importantly, the new system allows operators to place the stent more precisely than before.

"I've been deploying the SUPERA stent now for over a year.  The high radial force of the stent is particularly suited for biliary strictures.  The introduction of the SUPERA VERITAS system is a great complement to an outstanding stent," stated Mark Garcia, MD, Chief of Interventional Radiology at Christiana Care Health System in Wilmington, Delaware.

Gino Sedillo, MD, FACC of Bradenton Cardiology Center in Bradenton, Florida, is an investigator in the SFA trial.  He commented, "I've seen the SUPERA VERITAS system demonstrated, and was able to use it myself during a visit to Park Hospital in Leipzig, Germany.  The delivery steps have not only been greatly simplified, but there is also improved reliability and predictability of stent placement.  I look forward to incorporating the new delivery system into the ongoing prospective trial."

Don Jacobs, MD, a vascular surgeon at St. Louis University Hospital in St. Louis, Missouri, was asked to provide feedback on the new delivery system while in Leipzig, Germany and stated, "I was very impressed with the accuracy of the VERITAS system, and appreciated how it improved the ease of delivery of the SUPERA stent.  It represents a truly significant advance and adds significantly to an outstanding product package."

Commercial availability of the SUPERA VERITAS Transhepatic Biliary System is planned for the first quarter of 2011.