Zimmer Biomet Holdings announced the Pharmaceutical and Medical Devices Agency (PMDA) in Japan approved the iTaperloc Complete and iG7 Hip System, the world's first approved orthopedic implants with Iodine Technology that inhibits bacterial adhesion on the implant surface.
Implant-associated bacterial infection or Periprosthetic Joint Infection (PJI) remains one of the most common causes of revision and a challenging complication of total joint arthroplasty (TJA). PJI is estimated to occur in 1-2 per cent of primary TJA procedures and can have serious consequences. In fact, the mortality rate associated with PJI approaches the 5-year mortality observed in breast cancer (11 per cent) and far exceeds that of prostate cancer (1 per cent).
"Iodine Technology represents a significant advancement in orthopedic implant design," said Professor Hiroyuki Tsuchiya, Director at Yokohama Sakae Kyosai Hospital and Emeritus Professor of Orthopedic Surgery at Kanazawa University. Prof. Tsuchiya, who developed the technology, explained: "By integrating a controlled-release iodine layer through advanced anodization and electrophoresis, we created an implant that inhibits bacterial adhesion and biofilm formation during the postoperative period. This innovation combines simplicity and sophistication to help address the issue of PJI after total joint replacement."
iTaperloc and iG7 combine the long-standing clinical heritage of the Taperloc Complete Hip System and the simplicity, efficiency and performance of the G7 Acetabular System with Iodine Technology. Iodine is a biocompatible, essential body nutrient that does not cause antibiotic resistance and is commonly used in medicine as an antiseptic. Iodine Technology applies iodine to the implant's surface during the manufacturing process to inhibit biofilm formation.
"The earlier-than-expected approval of iTaperloc Complete and iG7 Hip System in Japan further strengthens Zimmer Biomet's comprehensive portfolio of infection management solutions, which spans prevention, detection, primary and revision products," said Ivan Tornos, Chairman, President & CEO, Zimmer Biomet. "By equipping surgeons with advanced tools to identify and address infection risks throughout the continuum of care, we're helping drive safer surgical outcomes. This milestone is the latest in our robust new product cycle and underscores our unwavering commitment to delivering first-to-world, transformative innovations that address the most meaningful challenges in musculoskeletal health."