CeloNova has announced US FDA 510(k) clearance expanding the indication for their Oncozene and Embozene microsphere products to now include the embolization of hepatocellular carcinoma.
Jane Ren, senior vice president and chief technology officer of CeloNova said: “Oncozene and Embozene microspheres are designed to provide selectivity, precision and consistencies with the goal of supporting our physicians to improve patient outcomes.”
Ziv J Haskal, professor, University of Virginia, commented, “It is very exciting to see a tumour-specific indication for a spherical embolic. The CeloNova microspheres offer a great potential value to my hepatoma patients.”
“The FDA’s clearance of Oncozene and Embozene for the embolization of Hepatoma provides support for another treatment option for physicians and patients in their battle against primary liver cancer,” said Martin J Landon, president and CEO of CeloNova.