WHAT IS PLATELET-RICH PLASMA (PRP)?
PRP, by definition refers to platelets in plasma, where the platelet concentration is generally considered to be twice the normal concentration in whole blood. Nowhere in the definition of PRP is there a description for including red blood cells (RBC) or white blood cells (WBC) – in fact, these cells should be removed as much as possible from a PRP preparation. Some kits that tout high platelet concentrations often do so at the expense of having contaminating RBCs or WBCs – these cells are known to have inflammatory and catabolic effects – just the opposite of the desired effect. If the PRP in the syringe has any tinge of pink or red, it is mostly likely that you are injecting a preparation that has RBC contamination. The ideal PRP solution will be a golden, straw-like color.
What is SELPHYL® PRFM?
The Selphyl® System is designed for the safe and rapid preparation of Platelet-rich Fibrin Matrix (PRFM) from a small sample of blood at the patient point of care. Many PRP systems require operator skill, have varying results and have extensive contamination with red blood cells and white blood cells. Selphyl® removes virtually all contaminating cells and is independent of operator technique. PRP is converted to PRFM through a controlled process, creating a scaffold that serves to protect and preserve platelets. Think of Selphyl® PRFM as the next generation PRP.
HOW IS SELPHYL® PLATELET-RICH FIBRIN MATRIX (PRFM) DIFFERENT?
The Selphyl® System is a completely closed system and can convert PRP to PRFM with the addition of a precise amount of calcium chloride, which initiates the conversion of fibrinogen to fibrin, as part of the clotting cascade. The fibrin matrix serves as a three dimensional scaffold to maintain the platelets at the site of injection. The scaffold also serves to protect the platelets so their release of growth factors can be sustained over a longer period of time.
The main advantages & benefits include:
Visual guide to quality
Completely Closed System
Fibrin Matrix scaffold
Sustained GF release
Extensive safety profile
Over 150K patients treated
What is the regulatory status of the SELPHYL® System?
The SELPHYL® System was cleared for marketing in 510(k) premarket notification number BK170096. Factor Medical, Inc. markets the Autologous Fibrin & Platelet System in this 510(k) under the trade names SELPHYL® and PRFM.