Biliary Stent Delivery Catheter Market Ready
The SUPERA Transhepatic Biliary System from IDEV Technologies received approval from the FDA to begin marketing. This new system is designed for the palliative treatment of biliary strictures resulting from malignancy. News of the product approval was posted on the Healthcare Sales and Marketing Network.
The system was created to work with the company’s SUPERA Self-expanding Biliary Stent. That tool provides more than 360 percent greater radial force than the other commercially available self expanding biliary stents comprised of laser cut nitinol tubing. The increased radial force is a function of the materials with which the stent is manufactured, wire interwoven nitinol (WIN). WIN promotes enhanced flexibility and radial force.
The system provides clinicians with increased control during placement procedures. The SUPERA incorporates a reciprocating ratchet mechanism which allows precise placement of the stent within the biliary tract. As well, the IDEV system is the first biliary stricture treatment system to provide a retrieval capability of almost 95 percent for a partially deployed SUPERA Biliary Stent.
The company is planning a launch of the SUPERA products across the United States. The company’s similar system was already approved for use in Europe. The product will be used for the first time at M.D. Anderson Medical Center shortly.
February 6, 2008 Related topics: Product Approval & Certification, Surgery, Hematology & Oncology