Embozene Color-Advanced Microspheres

Embozene Color-Advanced Microspheres are spherical, non-resorbable hydrogel microspheres coated with a perfluorinated polymer shell, supplied in pre-filled syringes. They are injected into the bloodstream to permanently occlude blood vessels for treating arteriovenous malformations, hypervascular tumors (including uterine fibroids and hepatoma), and benign prostatic hyperplasia. The device is not intended for neurovascular use.

Both the subject device and predicate are spherical, non-resorbable polymer microspheres delivered via microcatheter to embolize target vessels with the same indications for use and same technological characteristics. The only difference is that the subject device uses an updated syringe due to end-of-life of the previously used syringe, with no other technological changes.

ISO 17665-1, ISO 11138-1, ISO 11737-1, ISO 11737-2 (sterilization); ISO 10993-1 (biocompatibility); ISO 11607-1 and ISO 11607-2 (packaging integrity and shelf-life).

Substantial equivalence is based on identical indications for use and technological characteristics between subject and predicate devices. The only change—substitution of the syringe due to supplier discontinuation—has been evaluated for mechanical performance, biocompatibility, sterility, packaging, and shelf-life, and all device specifications of the predicate have been met. Therefore, the subject device performs identically to the legally marketed predicate despite the syringe component change.