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Selphyl® Science

The Selphyl® Process

1. 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.
2. The tube is then placed into a centrifuge and spun for six minutes to separate the blood into a supernatant plasma/platelet suspension.
3. The red and white blood cells are located below the cell separator gel.

4. The platelets and plasma are then transferred in a closed system to a second vacuum tube containing a small amount of calcium chloride solution.
5. Fibrin polymerization begins and the PRP remains liquid for approximately 10 minutes before forming PRFM.
6. The patient’s own PRFM is ready for use as deemed appropriate by the clinical use requirements.

The Selphyl® Kit

Affordable and Cost-effective

  • 4cc or 8cc of PRFM available for administration

A. STERILE TRAY WITH TYVEK® PEEL-BACK LID
B. SAFETY BLOOD COLLECTION SET — “Butterfly Wing”
C. PROPRIETARY VACUTAINER® PRP TUBE — “Yellow Top”

  • Proprietary 9cc whole blood collection tube with cell separator gel

D. DEVICE FOR THE STERILE TRANSFER OF FLUID

  • Safe, closed system
  • Needle protection sleeve (Jacketed)

E. PRFM PREPARATION TUBE — “Red Top”

  • 4cc liquid per tube
  • Hemogard™ Cap
  • Calcium Chloride Solution

F. ADDITIONAL MATERIALS REQUIRED (not included in the kit)

  • Alcohol swab, adhesive bandage, syringes and needles

 
Regulatory status: FDA cleared 510(k) Class II medical device

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

 
Whole Blood to PRFM Graphic

 
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.

 
Platelets Release Growth Factor

 
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.

 
Sustained Release of Growth Factors from PRFM

 

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.

1 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
2 Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma. Am J Sports Med. 2009; 37:2259-2272.

The Selphyl® System

 

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You are now entering the international portion of the website that has not been evaluated by the United States Food and Drug Administration. Information shown on the site may describe clearances in countries other than the United States, and therefore may contain indications and uses that are outside the scope of the FDA-cleared labelling. Information shown on this website is not intended to diagnose, treat, cure or prevent disease. Information on the product, packaging and publications is for informational purposes only and is not intended as a substitution for advice from a physician or health-care professional.