Implantable or insertable medical device resistant to microbial growth and biofilm formation

A method of manufacturing an implantable or insertable medical device comprising:

• providing a combination of (a) one or more biocompatible matrix polymers and (b) bioactive agents comprising an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor;
• processing said combination under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of any of said biocompatible matrix polymers and that substantially prevent chemical modification of said bioactive agents.

An implantable or insertable medical device comprising at least one biocompatible matrix polymer region comprising a material selected from the group consisting of ethylene vinyl acetate copolymers, copolymers of ethylene with acrylic acid or methacrylic acid, metallocene catalyzed polyethylenes and polyethylene copolymers, ionomers, vinyl aromatic copolymers, elastomeric polyurethanes and polyurethane copolymers, silicones and mixtures thereof;

• bioactive agents comprising an antimicrobial agent selected from the group consisting of triclosan, chlorhexidine and mixtures thereof;
• a microbial attachment/biofilm synthesis inhibitor selected from the group consisting of salicylic acid and salts and derivatives thereof, and, a radio-opacifying agent selected from the group consisting of bismuth subcarbonate, bismuth oxychloride, bismuth trioxide, barium sulfate, tungsten and mixtures thereof.