Onkos Surgical this week announced it received FDA de novo approval for its antibacterial coated implants.
According to the Parsippany, N.J.-based company, bacterial contamination of a permanent implant could have devastating effects in orthopedic oncology and revision arthroplasty.
“Implant contamination is a growing concern to the orthopaedic surgical community,” Dr. Steven Gitelis, chief medical officer, said in a news release. “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. The increasing prevalence of joint procedures underscores the importance of implementing effective strategies to address the presence of bacteria. The Onkos technology is a significant innovation and another option to help reduce local bacterial load on the implant.”
Medical Design & Outsourcing: How Orthobond’s antimicrobial coating prevents contamination of medical devices
Onkos Surgical said a robust body of preclinical safety and efficacy data was generated to support the de novo application. The data showed that the coating does not elute and has been proven to be bactericidal, with a 99.9% kill rate in in-vitro testing of bacteria found in the operating room.
“Receiving De Novo approval to market this technology represents a significant milestone for our surgeon customers and the patients they care for,” CEO and Co-founder Patrick Treacy said. “When it comes to implant bacterial contamination and failure, patient complications may include decreased limb function, amputation, and increased rates of mortality. We are proud to bring this meaningful solution to the market and we look forward to working with the regulatory agencies to expand the application of the technology across our portfolio of market-leading personalized and limb reconstructive implants. This exciting technology has the potential to be one of the most important advances in orthopedic medical devices in decades.”
The antibacterial coating’s effectiveness has not been shown in human clinical trials to prevent or reduce infection rates.
Onkos used device developer Orthobond‘s Ostaguard antibacterial coating technology, Orthobond CEO David Nichols said. Orthobond has already won FDA de novo approval for another implant coated with its technology, and is looking to partner with other device developers.
