NEWNAN, Ga., Dec. 16 /PRNewswire/ -- CeloNova BioSciences, Inc., announced today that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for Embozene(TM) 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). U.S. commercial sales of Embozene(TM) Microspheres will begin immediately.
Embozene(TM) 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 micrometers, 100 micrometers, 250 micrometers, 400 micrometers, 500 micrometers, 700 micrometers, and 900 micrometers 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 micrometers, 1100 micrometers and 1300 micrometers, for a total of ten sizes including the smallest and the largest microspheres available for endovascular therapy. CeloNova is the only Company that provides this complete range of products.
CeloNova's Embozene(TM) Microspheres consist of a hydrogel core and an exterior shell made from Polyzene(R)-F, CeloNova's proprietary polymer which is known to be anti-inflammatory and bacterial-resistant. Four design features distinguish Embozene(TM) Microspheres from other spherical embolics: biocompatibility, precise calibration, stable suspension, and structural stability. Embozene(TM) Microspheres are precisely calibrated, they retain their shape after passing through a catheter, and they 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.
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, MD, 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(TM) Microspheres maintain suspension better than any other embolic I've seen," said Dr. Lipman. "I'm looking forward to using this therapy in my practice."
"From the outset, we took a different approach to developing our Embozene(TM) Microspheres by asking physicians and medical scientists for the qualities and characteristics that the ideal embolic device should have," said Thomas A. Gordy, President and Chief Executive Officer, CeloNova BioSciences, Inc. "Then, we engineered Embozene(TM) Microspheres to have those properties, which are made even better with Polyzene(R)-F, our proprietary polymer. Polyzene(R)-F helps make our leading-edge technology better."
For more information about CeloNova BioSciences, visit www.celonova.com. To place an order for Embozene(TM) Microspheres, call 888-388-3888 to reach your local sales representative or e-mail firstname.lastname@example.org.
About CeloNova BioSciences, Inc.
Headquartered in Newnan, near Atlanta, Georgia, CeloNova BioSciences, Inc., is a developer of novel medical devices that are then enhanced by one of the Company's proprietary materials, Polyzene(R)-F. Polyzene(R)-F is highly lubricious, anti-inflammatory, and bacterial-resistant making it an ideal surface treatment for implanted medical devices. The Company's current products include its Embozene(TM) Color-Advanced Microspheres and the CATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F. Other innovative devices are currently in the company's developmental pipeline. For more information, please visit www.celonova.com.
Polyzene(R)-F is a synthesized inorganic chemical compound with an extensive array 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. Polyzene(R)-F can be customized for the desired application and applied in a variety of ways including as a coating, extrusion, weaving, or electro-spinning. The base substrate will be endowed with the properties of the polymer.
CONTACT: Robert J. Murphy
The Storch-Murphy Group 908-276-0777
|SOURCE CeloNova BioSciences, Inc.|
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