The FDA has approved Zimmer Biomet's Synovasure Lateral Flow Test Kit — a device used to determine infection around a joint replacement in the lubricating fluid of patients being evaluated for revision surgery.
Four insights:
1. The device aims to safeguard against revision surgery — surgery performed to replace or compensate for a failed implant.
2. Synovasure detects antimicrobial proteins proteins in the fluid of patients around the joint, which are released by white blood cells in response to infection.
3. It is intended as an aid to determine whether there is an infection in the lubricating fluid, not to pinpoint a specific type of infection.
4. It is designed for use with other clinical findings while diagnosing a patient's prosthetic joint infection.
"With this test, healthcare professionals now have an additional option available to aid their clinical assessment as to whether the patient has an infection and requires revision surgery," said Tim Stenzel, MD, PhD, director of the office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.