Color-Coded Embolic Microspheres Treat Hypervascularized Tumors and Arteriovenous Malformations Better

(Newnan, GA, USA) has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) 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 AVMs (defects in the circulatory system).

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.

CeloNova's Embozene microspheres consist of a hydrogel core and an exterior shell made from Polyzene-F, CeloNova's proprietary polymer, which is known to be anti-inflammatory and bacterial-resistant. Four design features distinguish Embozene microspheres from other spherical embolics: biocompatibility, precise calibration, stable suspension, and structural stability. Embozene microspheres are precisely calibrated; they retain their shape after passing through a catheter, and can stay in suspension for an extended time. The unique color enhancement of the microspheres and finely calibrated sizes make selection easy, efficient, and precise for the operator. The result is an embolic microsphere that provides accurate and complete vessel occlusion.

"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 (GA, USA). "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.

Embozene microspheres are the first to be color-enhanced with a different color for each size for increased procedural safety, efficiency, and visibility. 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 3 additional sizes, 75 µm, 1100 µm, and 1,300 µm, for a total of 10 sizes including the smallest and the largest microspheres available for endovascular therapy.

CeloNova BioSciences is a developer of novel medical devices that are then enhanced by one of the company's proprietary materials, Polyzene-F. Polyzene-F is highly lubricious, anti-inflammatory, and bacterial-resistant making it a suitable surface treatment for implanted medical devices. The company's current products include its Embozene Color-Advanced microspheres and the Catania coronary stent system with NanoThin Polyzene-F.

Polyzene-F is a synthesized inorganic chemical compound with an extensive
range of bioscience and industrial applications that can be applied as a surface coating ranging in thickness from less than 50 nanometers to more than 200 nanometers. The polymer can be applied to or mixed with other substances to allow for a diverse range of applications on a multitude of substrates, including other polymers, metals, and ceramics.

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