The US Food and Drug Administration (FDA) has granted 510(K) approval to Cytomedix to use its Angel Concentrated Platelet Rich Plasma (cPRP) system to process a small sample of blood or a mixture of blood and bone marrow aspirate.
Designed for use in the clinic or intraoperatively at the point-of care, the system combines PRP with bone graft material and used in appropriate orthopedic procedures such as spinal fusion, healing of non-union bone fractures and other bone grafting applications.
The Angel cPRP system, in comparison to other commercially available systems, produces high platelet yields, significant reduction in pro-inflammatory cells, rapid processing time, adjustable hematocrit from 0%-25%, and flexible final cPRP volumes.
In addition, the proprietary software automatically adjusts the separation parameters to deliver a consistent product.
Cytomedix chief executive officer Martin Rosendale said, "This is a significant market opportunity for Cytomedix as Angel cPRP will be positioned as a 'best in class' device that offers important competitive advantages including high platelet concentration capacity, efficient reduction of inflammatory cells, and an automated, closed system for all surgical settings."
