Medical device company SI-BONE has secured the US Food and Drug Administration (FDA) 510(k) clearance on a revised indication statement to extend the application of its iFuse Implant System (iFuse).
Studies have demonstrated the device’s ability to reduce pain, resulting in improved patient function and quality of life.
The revised indication statement is based on the safety and effectiveness data from retrospective studies, as well as three prospective clinical trials conducted on the iFuse.
SI-BONE president and CEO Jeffrey Dunn said: "This is a significant milestone in the evolution of the treatment of SI joint dysfunction and clearly sets iFuse apart from any other surgical treatment option.
"No other surgical treatment option for SI joint dysfunction is supported by prospective data and now with over 21,000 procedures performed worldwide, iFuse is clearly the surgical treatment of choice for SI joint dysfunction due to SI joint disruption or degenerative sacroiliitis."
The iFuse Implant is a minimally invasive surgical device, which features a patented triangular shape that provides 31 times the rotational resistance of a screw.
The device features titanium implants coated with a porous titanium plasma spray (TPS), providing an interference surface to decrease implant motion and allow biological fixation to support long-term fusion.
It is intended to be used for sacroiliac fusion for conditions such as sacroiliac joint dysfunction, which is a result of sacroiliac joint disruption and degenerative sacroiliitis.
It comprises conditions whose symptoms begin during pregnancy or the peripartum period, and have lasted postpartum for more than six months.