Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

The Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology is a ventricular and distal drainage catheter system used to treat hydrocephalus by draining excess cerebrospinal fluid from the brain's ventricles into the peritoneal cavity or other body locations. The catheters are impregnated with two antibiotics (rifampicin and clindamycin hydrochloride) to reduce bacterial colonization and include barium sulfate for radiopacity and ink markings for positioning.

The proposed device adds Endexo®, a surface-modifying macromolecule polymer, to the base silicone compared to the predicate. Markings changed from tantalum dots to implant-grade ink with circumferential bands. A new 23 cm ventricular catheter length is offered alongside the existing 14 cm option. The stylet now has a square cross-section instead of circular and a longer version for the 23 cm catheter. Catheters now feature a translucent design with a radiopaque barium sulfate stripe instead of full radiopacity. Sterilization method differs (E-beam vs. steam) and MRI compatibility changed from MR-conditional to MR-safe.

ISO 7197, ASTM F647-94, ASTM D412-16, ASTM F2053-20, IEC 62366-1, ISO 10993 series (cytotoxicity, sensitization, irritation, acute/subacute toxicity, pyrogenicity, genotoxicity, implantation, chronic toxicity, hemocompatibility, carcinogenicity), ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2.

The proposed device maintains the same intended use, functionality, and antimicrobial agents as the predicate device (K233445). All modifications—Endexo addition, ink markings, new catheter length, stylet shape, radiopacity design, and sterilization method—represent continuous improvements in usability and safety rather than fundamental changes in how the device works. Comprehensive bench testing and biocompatibility studies demonstrate equivalent or superior performance (including reduced thrombosis), and both sterilization methods achieve the same SAL of 10⁻⁶. The changes do not raise different questions of safety and effectiveness because the device retains its core mechanism and demonstrates safe biocompatibility across all tested parameters.