FDA Approves Medafor's Arista(TM) AH Absorbable Surgical Hemostat for U.S. Operating Rooms
MINNEAPOLIS, Oct. 3-- Medafor, Inc. announced today that its Arista(TM) AH Absorbable Hemostat has received FDA approval to be marketed within the United States. Arista AH has been distributed internationally since 2002 and has compiled a remarkable record of surgical success around the world. In the U.S., this easy-to-use, efficacious and safe hemostat is indicated for most types of surgery including cardiac, orthopedic, spinal and general surgical applications.
Arista AH consists of Medafor's patented Microporous Polysaccharide Hemospheres (MPH®), a plant-based, flowable powder engineered to rapidly dehydrate blood, enhancing clotting on contact. Arista AH facilitates the formation of a highly resilient, natural clot within just a few minutes regardless of the patient's coagulation status.
Arista AH is the only new generation surgical hemostat that is instantly ready to use, requiring no mixing, no addition of patient blood or other components and no special handling or storage conditions. Pre-clinical evaluations, clinical studies and surgical use have shown the hemostatic capabilities of Arista AH to be comparable to the current popular choice of surgical hemostatic materials while its unique formulation allows for rapid absorption. Arista AH is fully absorbable with studies substantiating no trace of the material at the wound site within 24 to 48 hours of application, and because Arista AH degrades rapidly, it does not promote infection.
"The introduction of Arista AH to the surgical market represents a major shift in the means available to surgeons when considering their patients' care and safety," said Gary Shope, Medafor C.E.O. "Surgeons can choose Arista AH with the confidence that its quality and efficacy are consistent, its unique formulation eliminates risks associated with animal and human derived products and it is always ready to apply the instant they need it."
For further information about Medafor's technology, research and products, please visit www.medafor.com/ .
Medafor, Inc., is a privately held Minnesota Corporation based in Minneapolis.
Web site: www.medafor.com/