News | January 25, 2009

Color-Coded Embolic with Polyzene-F Coating Gains FDA Clearance for Arteriovenous Malformations

January 26, 2009 - CeloNova BioSciences Inc. recently received FDA 510(k) marketing clearance for Embozene Color-Advanced Microspheres, which are indicated for the treatment of hypervascularized tumors (tumors with a large number of blood vessels in many locations) and arteriovenous malformations (defects in the circulatory system).

Embozene Microspheres are the first microspheres to be color-enhanced with a different color for each size for increased procedural safety, efficiency and visibility, the company said. They are also reportedly available in a wider range of sizes than any other spherical embolic on the market. They are available in 40 µm, 100 µm, 250 µm, 400 µm, 500 µm, 700 µm, and 900 µm sizes in 1 ml and 2 ml pre-filled syringes and vials. CeloNova plans to submit a supplemental 510(k) to the FDA to add three additional sizes, 75 µm, 1100 µm and 1,300 µm.

CeloNova’s Embozene Microspheres consist of a hydrogel core and an exterior shell made from Polyzene-F, CeloNova’s proprietary polymer that is anti-inflammatory and bacterial-resistant. The spheres reportedly offer biocompatibility, precise calibration, stable suspension and structural stability. The company said Embozene Microspheres retain their shape after passing through a catheter, and they can stay in suspension for an extended time.

Embolization is a minimally invasive procedure used to control or prevent abnormal bleeding, to shrink tumors by blocking the blood vessels that supply them, and to block off blood vessel malformations. Physicians use enhanced imaging techniques to visualize the blood vessel, then insert and advance a catheter to the treatment site. The embolic agent is then released into the catheter and positioned within the blood vessel or malformation to block the target vessel permanently.

“Embozene Microspheres are an innovative advance in embolic technology that has been well received outside the U.S.,” said John C. Lipman, M.D., FSIR, founder and CEO of the Atlanta Interventional Institute and director of the Center for Image-Guided Medicine at Emory-Adventist Hospital Atlanta. “Intuitively, a polymer that is anti-inflammatory and that provides more finely calibrated bead sizes, shape integrity, prolonged suspension, and has a unique color-coded selection system that makes for more efficient procedures, will appeal to physicians as well as patients. Embozene Microspheres maintain suspension better than any other embolic I’ve seen,” said Dr. Lipman.

For more information:

Overlay Init