The FoThe US Food and Drug Administration (FDA) has granted 510(k) clearance for the 6 French (6Fr) Supera Veritas transhepatic biliary stent system (IDEV Technologies). The new lower profile system, approved for sale outside the USA earlier this year, is the latest enhancement to the delivery catheter utilised with the Supera stent, currently cleared in the USA for palliative treatment of biliary strictures produced by malignant neoplasms.
In addition to having a lower entry profile, the new 6Fr system is available in two catheter lengths, 80 cm and 120 cm, and offers even better efficiency and trackability.
“Feedback from our European customers confirms the new 6Fr system allows for improved ease of use, trackability and control of stent deployment,” commented Christopher M Owens, president and CEO of IDEV. “As the global market continues to move toward smaller delivery sizes, we believe these regulatory clearances will provide an opportunity to accelerate market expansion and adoption of our technology. We are pleased to now have this product available to our US customers and patients.”
Full commercial launch of the 6Fr Supera Veritas transhepatic biliary stent system is anticipated in January 2012.
The Supera stent is currently approved in Europe, Canada, Australia and Hong Kong for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty.