FDA approves new concentrated platelet rich plasma system (Helio)
Cytomedix Inc. received FDA clearance for the use of its Angel Concentrated Platelet Rich Plasma System for processing a small sample of blood or a mixture of blood and bone marrow aspirate.
The Angel Concentrated Platelet Rich Plasma (cPRP) System is intended for use in the clinic of intraoperatively at the point of care for the safe and rapid preparation of PRP from a small sample of whole blood or a small mixture of blood and bone marrow. According to a company press release, the cPRP system has high platelet yields, significant reduction in proinflammatory cells, rapid processing time, adjustable hematocrit from 0% to 25% and flexible final cPRP volumes.
“We are pleased to reach this important regulatory milestone that will broaden utilization of the Angel cPRP System in a range of orthopedic procedures,” Martin Rosendale, chief executive officer of Cytomedix, stated in the release. “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.”