ABOUT PRP
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:
- SUPERIOR TECHNOLOGY
- VISUAL GUIDE TO QUALITY
- COMPLETELY CLOSED SYSTEM
- ULTRAPURE PRFM
- OPERATOR INDEPENDENT
- FIBRIN MATRIX SCAFFOLD
- VIABLE PLATELETS
- 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 under premarket notification (510(k)) submission numbers BK120009 and BK120008. Factor Medical, LLC in conjunction with Cascade Medical Enterprises, LLC markets the FIBRINET® Autologous Fibrin & Platelet System in the U.S. under the trade name Selphyl® PRFM. The CE mark certification has been granted in Europe.
HOW IT WORKS
HOW LONG DOES THE PROCEDURE TAKE?
The entire procedure takes about 30 minutes to perform in your doctor’s office.
HOW MANY TREATMENTS ARE NEEDED?
The number of treatments needed depends on each individual patient, the desired outcome, and your doctor’s treatment plan.
IS THE TREATMENT PAINFUL?
Unlike other products that are acidic (low pH), Selphyl® PRFM has close to physiologic pH. There may be some temporary discomfort during the injections. Like all injection procedures, one can experience occasional redness and bruising immediately following the treatment that resolves quickly.
ARE THERE ANY SIDE EFFECTS?
There have been no known side effects associated with Selphyl® reported to date. As with any injectable procedure, some patients may experience some mild and temporary irritation, swelling, bruising, itching, discoloration or tenderness at the injection site.
CAN ANYONE BE ALLERGIC TO SELPHYL®?
There is virtually no risk of allergic reaction. The Selphyl® PRFM System is used to rapidly collect and isolate a patient’s own PRFM for injection and contains no animal or synthetic products.
SELPHYL® SCIENCE
THE SELPHYL® PROCESS
- During a short office visit (30 minutes), a small amount of a patient’s own blood is drawn into a vacuum collection tube containing a cell separator gel.
- The tube is then placed into a centrifuge and spun for six minutes to separate the blood into a supernatant plasma/platelet suspension.
- The red and white blood cells are located below the cell separator gel.
- The platelets and plasma are then transferred in a closed system to a second vacuum tube containing a small amount of calcium chloride solution.
- Fibrin polymerization begins and the PRP remains liquid for approximately 10 minutes before forming PRFM. The patient’s own PRFM is ready for use as deemed appropriate by the clinical use requirements.
THE POWER OF BLOOD
As part of the body’s capacity to heal itself, platelets and other components in human blood migrate to a site of injury. Platelets are known to release a variety of factors that respond to tissue injury, where they initiate and promote healing. By concentrating platelets at the site of injury, physicians have the potential to enhance the body’s natural capacity for healing.1,2
The Selphyl® System provides the exact amount of Calcium Chloride to PRP producing Platelet-rich Fibrin Matrix. Other systems produce PRP, not PRFM. Fibrin matrix creates a scaffold to localize platelets to the site of injection and allows for sustained growth factor release, migration of stem cells and reservoir for regenerative signaling.
PLATELETS RELEASE GROWTH FACTOR
As soon as Selphyl®-prepared PRFM is administered, growth factors are released through the formation of a three-dimensional cross-linked fibrin matrix which is essential to the platelet plug as it serves as a binding site for both platelets and growth factors allowing their sustained release.
This scaffolding (fibrin matrix) localizes the growth factors increasing their concentration at the desired location and guiding tissue regeneration. Studies have shown that platelet growth factors are released for up to seven days, supporting collagen production and increased vascularization, which results in overall skin improvements.
ULTRAPURE PRFM “LIQUID GOLD”
Selphyl® is based on the principle that human blood and platelets possess all the essential elements needed for tissue. It is designed to produce PRFM devoid of contaminating red and white blood cells. Other Systems are designed to collect white blood cells for diagnostic testing. The proprietary gel separator design is one of the key advantages of the Selphyl® System.
- Anitua E, Andia I, Ardanza B, Nurden P, Nurden AT. Autologous platelets as a source of proteins for healing and tissue regeneration. Thromb Haemost. 2004; 91(1):4-15
- Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma. Am J Sports Med. 2009; 37:2259-2272.
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