Arteriocyte Medical Systems, Inc. announced today approval by the U.S. Food and Drug Administration (FDA) to manufacture and distribute the Arteriocyte Medical Systems brand of Anticoagulant Citrate Dextrose Solution, USP (ACD-A) for use with its Magellan® Platelet Separation System.
The new single use package of 50cc volume ACD-A solution will replace the company's currently available smaller 30cc volume ACD-A vials in the Magellan® surgical convenience kits.
Arteriocyte Medical Systems' lead product is the Magellan® Autologous Platelet Separator System. The Magellan® system is an FDA 510(k) cleared medical device for the rapid production of platelet rich plasma from blood and bone marrow that can be applied to a surgical site as surgeons deem necessary. Magellan® MAR01™ technology enables the rapid Operating Room based "closed system" concentration of aspirated bone marrow, yielding a bedside prepared product rich in platelets, hematopoietic stem cells and mesenchymal stem cells in as little as fifteen minutes.