FDA grants 510(k) clearance for IDEV stent delivery catheter

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IDEV Technologies, a developer and marketer of minimally invasive stent technologies, has received the FDA’s 510(k) clearance for its new Supera Biliary Stent delivery catheter.

The Houston-based IDEV said its improved Supera Transhepatic Biliary System is indicated for the palliative treatment of biliary strictures produced by malignant neoplasms.

The Supera Biliary Stent delivery catheter also provides the operator with enhanced control during a procedure with a reciprocating ratchet mechanism that allows the operator to place the stent in the biliary tract, according to the company.