Zimmer Biomet (NYSE: ZBH) has won Japanese regulatory approval for a total hip system that features infection-resistant coating technology, which it describes as a first.
According to ZB, the iTaperloc Complete and iG7 hip system are the world’s first approved orthopedic implants with iodine coating technology that inhibits bacterial adhesion on the implant surface.
During a July earnings call, Zimmer Biomet CEO Ivan Tornos briefly mentioned the iodine technology, describing it as transformational and stating that there was a path to market the technology in the U.S.
The iodine coating technology matters because periprosthetic joint infection (PJI) is a serious complication affecting 1–2% of primary arthroplasties. Research published this year says the mortality rate of a total hip PJI is comparable to that of breast cancer.
“Iodine Technology represents a significant advancement in orthopedic implant design,” Hiroyuki Tsuchiya, director at Yokohama Sakae Kyosai Hospital and emeritus professor of orthopedic surgery at Kanazawa University, said in a news release.
Iodine is an essential body nutrient and a commonly used medical antiseptic that is biocompatible and does not cause antibiotic resistance. The ZB coating technology involves applying iodine to the implant’s surface during the manufacturing process to inhibit biofilm formation.
Tsuchiya, who developed the technology, added: “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.”
In the news release published on Sept. 25, Tornos hailed the Pharmaceutical and Medical Devices Agency (PMDA) approval in Japan.
“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,” Tornos said.
“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.”
