Boston Scientific showed at the Global Embolization Cancer Symposium and Technologies (GEST US; 17–19 May, Miami Beach, USA) meeting that the US Food and Drug Administration (FDA) has approved an expanded indication for Embozene making it on-label for use in prostate artery embolization treatment in the USA.
As conveyed by Boston Scientific to its US customers, the full indication for Embozene is as follows: “Embozene microspheres are intended for the embolization of arteriovenous malformations
and hypervascular tumours, including uterine fibroids and hepatoma, and for embolization of prostatic arteries for symptomatic benign prostatic hyperplasia.”
In addition to the general embolization contraindications, warnings and adverse events, additional contraindications, warnings and adverse events specific to the prostatic artery embolization procedure were also notified.
“Embozene microspheres are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with Polyzene-F, a proprietary polymer. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter and colour-coded by size to allow for easy identification,” Material on the company’s website states.
Microspheres are packaged in single syringe units with 2mL of product in 20 mL syringes.
Publically available documents in relation to the US FDA approval reveal that the expanded indication was cleared on the basis that Embozene is substantially equivalent to the legally marketed Embosphere (Merit Medical) microspheres, cleared by the FDA, with regard to indications for use and technological characteristics.
“Both devices are spherical, non-resorbable polymer microspheres which are delivered through a microcatheter to embolize the target vessel. There are differences in actual material composition; however, the materials of Embozene are well-known and widely used in the medical environment and are biocompatible for their intended use,” the documents state.
“The devices are available in similar sizes, Embozene (40–1300 µm) vs. Embosphere (40–1200 µm). The differences in materials and size range of these devices do not affect overall safety or effectiveness as demonstrated by clinical data,” the FDA material that is available online, states.
