Medafor Inc announced that its breakthrough surgical hemostat, Arista AH, has received CE mark for intra-operative surgical applications. The Company will now actively market to a range of surgical indications in Europe through its recently opened international service center in Munich, Germany.
Medafor CEO Richard Zerban said, "CE certification was a timely achievement that provides Medafor the opportunity to expand the use of its innovative technology throughout the European surgical arena. Countries outside the EU also recognize the CE mark as a compliance standard and permit immediate market entrance." Product sales of Arista AH have commenced through newly signed distribution agreements in Germany, Belgium, France, Italy, Spain, and Greece.
Medafor''''s related products have already received Federal Food and Drug Administration (FDA) approval for topical use in the United States.
TraumaDEX has been cleared for use by doctors and medical services personnel for temporary control of severe bleeding in a variety of trauma and post surgical wounds. HemaDerm has been cleared to treat bleeding in dermatological procedures and vascular access sites. Bleed-X has been approved for over-the-counter use for cuts, lacerations and abrasions. These products and Arista AH are based on Medafor''''s MPH (Microporous Polysaccharide Hemospheres) technology -- a biopolymeric, microporous powder which produces rapid hemostasis in areas of profuse bleeding.
MPH is a novel hemostatic technology, which, when applied to a bleeding wound site, initiates coagulation within seconds. The particles act as molecular sieves to absorb fluids in the blood, attracting and concentrating proteins and platelets and accelerating the natural clotting cascade.