WEBSTER, Texas, Nov. 3, 2010 /PRNewswire/ — 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
“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