IDEV Technologies (IDEV), a provider of minimally invasive medical technologies, has received the US Food and Drug Administration (FDA) 510(k) clearance to market the Supera Veritas Transhepatic Biliary System.
Supera Veritas is the delivery system for IDEV’s Supera wire interwoven nitinol stent, currently cleared in the US 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 US, for treatment of peripheral arterial disease of the superficial femoral artery (SFA).
IDEV president and CEO Christopher Owens said that the clearance of the Supera Veritas system represents the culmination of a strong effort to respond to customer needs and the result is a system that provides a competitive advantage, and may represent a paradigm shift in how patients are treated.
IDEV said that the new device provides easier deployment of the Supera stent compared to earlier systems, eliminating multiple steps previously required for preparation and delivery and also allows operators to place the stent more precisely than before.