FDA delivers de novo clearances to 2 novel antibacterial implant coatings

The FDA has handed out groundbreaking green lights to a pair of novel antibacterial coatings that each aim to keep implants as clean as possible during their short trip in the operating room from packaging to patient.

Though the initial de novo clearances cover spine and orthopedic hardware, the two developers—Orthobond and Onkos Surgical—said they believe their respective, proprietary disinfectants could one day be used to help shield a wide variety of implant types.

Orthobond’s Ostaguard surface treatment, for example, applies a non-eluting coating that mechanically kills bacteria as they land on the surface of a medical device—without using antimicrobial agents and still being safe for long-term human use. 

Ostaguard was first cleared for the company’s Mariner pedicle screw system used in spinal fusion procedures—though Orthobond said it plans to develop the coating for joint replacements, sports medicine and plastic surgery as well as cardiovascular and neuromodulation implants along with potentially nonmedical purposes in textiles and consumer products.

According to the company, studies have shown that between 70% and 100% of failed joint implants removed from patients have displayed some level of contamination. 

“We believe our surface coating has the potential to be the standard of care for implantable devices to protect patients from pathogens, and that this will be transformative to the field of surgery and beyond,” Orthobond CEO David Nichols said in a statement

Meanwhile, Onkos Surgical’s clearance allows its ELEOSx limb salvage system and coating to be used in the replacement of leg bones following degenerative joint diseases such as osteoarthritis, or after surgeries to remove a cancerous tumor or treat severe trauma.

“Implant contamination is a growing concern to the orthopaedic surgical community,” said Steven Gitelis, M.D., Onkos’ chief medical officer and director of musculoskeletal oncology at Rush Cancer Center. “When bacteria contaminate the artificial joint, it can lead to a cascade of issues that can significantly impact the patient’s health. The current tools in our armamentarium are simply not enough to help solve this multifactorial problem.”

Both developers employ a quaternary ammonium compound—a common type of ingredient in disinfectants for bacteria, viruses and mold—that is covalently bonded with the implant. However, neither company has put forward clinical trial data that track their coatings’ impact on a patient’s risk of infection over time, according to the FDA.