CoorsTek Medical announced the first human implantation of Integrity-SI™ Fusion minimally invasive sacroiliac fusion implants, developed in collaboration with the Mayo Clinic to address sacroiliac joint dysfunction. CoorsTek will manage initial limited launch and study of the system, and seeks to partner with OEMs for commercialization and distribution.
The system received FDA 510(k) clearance in December 2016, cleared for use with or without hydroxyapatite coating.
The Integrity-SI Fusion technique employs thorough joint preparation, compression and stability via the proprietary instrumentation. It also uses proprietary BladeX MIS decortication technology with a rigid, deployable cutter that aggressively prepares the joint surface through a cannula, and creates an optimum space using single-use, disposable blades, delivering maximal bone graft. The system uses one incision to insert the single implant, or a primary plus a secondary implant for rotation stability, per surgeon preference.
Source: CoorsTek Medical