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news.CeloNova BioSciences, a developer of medical devices, has received 510(k) marketing clearance from the FDA for Embozene color-advanced microspheres which are indicated for the treatment of hypervascularized tumors and arteriovenous malformations.
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According to the company, Embozene microspheres are the first and only microspheres to be color-enhanced with a different color for each size for increased procedural safety, efficiency and visibility. They are also available in a wider range of sizes than any other spherical embolic on the market. They are available in 40, 100, 250, 400, 500, 700, and 900 micrometers sizes in 1ml and 2ml pre-filled syringes and vials.
CeloNova plans to submit a supplemental 510(k) to the FDA to add three additional sizes, 75, 1100 and 1300 micrometers, for a total of 10 sizes including the smallest and the largest microspheres available for endovascular therapy.
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.
John Lipman, founder and CEO of the Atlanta Interventional Institute and director of the Center for Image-Guided Medicine at Emory-Adventist Hospital Atlanta, said: Embozene microspheres are an innovative advance in embolic technology that has been well received outside the US.
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.