FDA clears Idev transhepatic biliary stent system
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Idev Technologies' 6 French (6Fr) Supera Veritas transhepatic biliary stent system.
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Idev Technologies’ 6 French (6Fr) Supera Veritas transhepatic biliary stent system.
The new lower profile system is available in two catheter lengths, 80cm and 120cm, and is designed for palliative treatment of biliary strictures produced by malignant neoplasms.
Idev Technologies president and CEO Christopher Owens said that the new 6Fr system allows for improved ease of use, trackability and control of stent deployment.
The company plans to launch the Supera Veritas transhepatic biliary stent system in January 2012.