A new antimicrobial coating could go a long way in keeping medical devices free of infection-causing microbes after winning FDA de novo approval for its first indication. Device developer Orthobond says its proprietary Ostaguard antimicrobial coating offers a new defense against bacteria, viruses and fungi that could contaminate the surface of an implantable device before it’s placed inside a patient.
The initial FDA approval is for Ostaguard-coated pedicle screws used in spinal fusions, but Orthobond said it has other devices treated with the technology in various stages of the regulatory process. An Ostaguard-coated oncology device from Onkos Surgical has also won FDA de novo approval.
Orthobond Corp. said the Food and Drug Administration approved its request to market Ostaguard, an antibacterial surface treatment used on permanent spine implants.
This is the first time the FDA granted approval for a medical device with a non-eluting coating created to actively kill bacteria contaminating surfaces, the company said. Studies have found 70% to 100% of failed joint implants show some level of contamination with consequent pain and restricted mobility, Orthobond said.
A new antimicrobial coating could go a long way in keeping medical devices free of infection-causing microbes after winning FDA de novo approval for its first indication.
Device developer Orthobond says its proprietary Ostaguard antimicrobial coating offers a new defense against bacteria, viruses and fungi that could contaminate the surface of an implantable device before it’s placed inside a patient.
Orthobondhas gained U.S. Food and Drug Administration De Novo approval for Ostaguard, the company’s antibacterial surface treatment, on a permanent medical device.
The company said this is the first FDA de novo nod for a non-eluting coating to actively kill bacteria that contaminate a medical device’s surface. Its initial application is in orthopedic spinal implants.
Orthobond, a leader in covalently-bound antimicrobial surface treatments with broad applications in the medical device industry announced today the appointment of Frank P. Cammisa, MD, as the company’s Chief Medical Officer. In this role Dr. Cammisa will provide leadership in clinical research and commercial applications for the technology. “Dr. Cammisa brings a proven track record of addressing gaps in patient treatment including his research into the presence of bacteria during spinal surgery and its role towards poor clinical results,” said David Nichols, CEO at Orthobond. “His expertise in providing key insights in this field along with his record of scientific research are skills we are excited to have him bring to Orthobond.”
“Device designs have seen significant advances in the past decade; however, the need to eliminate bacterial contamination of the surgical instruments and implants in the operating room environment has not been solved. Orthobond’s technology shows great efficacy against the most common strains of bacteria. I am excited to help guide the team through the key testing to prove safety and efficacy and provide a novel solution to a significant healthcare burden,” said Dr. Cammisa.
