Tornus ES

The Tornus ES is a rotary-operated dilator device used to widen strictures in bile ducts and pancreatic ducts, and to create openings through the stomach or duodenum wall. It is indicated for adult patients only and operates by rotating a handle that advances the device like a screw due to its spiral-wound coil design.

The device features a dual-coil design (wire coil upper layer, rope coil under layer) with a tapered distal tip coated in resin and hydrophilic material. It is 195 cm in effective length with a 7 Fr outer diameter, compatible with 0.018" or 0.025" guidewires, made of stainless steel and polyurethane, and sterilized via ethylene oxide with a 3-year shelf life.

ISO 10993 (biocompatibility testing including cytotoxicity, sensitization, irritation, and systemic toxicity), ISO 11135:2014 (sterilization validation for ethylene oxide), and ISO 10993-7:2008 (residual gas limits). Non-clinical bench testing assessed appearance, tensile strength, guidewire pass-through, dilation ability, kink resistance, and torsional strength.

The Tornus ES has the same intended use as the predicate Soehendra Biliary Dilation Catheter (dilating biliary strictures in adults) and operates on the same principle—a rotary mechanism with a tapered distal tip. While the subject device supports transgastric/transduodenal access in addition to standard biliary access, this difference in access point does not introduce new safety or effectiveness questions because the device uses established materials, coatings, and design principles substantially similar to the predicate. Non-clinical performance testing confirms the device functions equivalently to the predicate across all critical parameters.