The FDA has cleared SI-BONE's iFuse Implant System to include the following in its indication statement — "clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function and quality of life at 12 months post-implantation."
Here are three things to know:
1. The new full indication for use statement states: "The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than six months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function and quality of life at 12-months post-implantation."
2. The addition was cleared based on prospective and retrospective clinical studies.
3. The studies showed that the system was associated with consistent improvement in pain, patient function and quality of life at 12-months.