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The Selphyl® System enables the safe and rapid preparation of autologous platelet-rich plasma (PRP) for injection. A small volume of the patient’s blood is collected and the platelets and fibrin are concentrated during a simple, reproducible process. The resulting product is liquid, gel or membrane.
Selphyl ensures a preparation of fibrin and platelets, with virtually no red or white blood cells. Studies have shown these platelets to be viable and intact. Platelets will release proteins, which have been reported to trigger cell migration, proliferation and differentiation over time.
There have been more than 15,000 procedures performed world-wide.
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 Platelet-rich Fibrin Matrix (PRFM).
6. The PRFM is ready for use as deemed appropriate by the clinical use requirements.
The Selphyl Kit
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
- BD HemogardTM Cap
-Calcium chloride solution
F. Additional materials required (not included in the kit)
- Alcohol swab, adhesive bandage, syringes and needles
Regulatory status: FDA cleared Class II device (510(k) #BK020051 & BK060006) and CE mark
The Selphyl® System is manufactured by Cascade Medical Enterprises, LLC, and licensed to Aesthetic Factors, LLC.
Selphyl is intended for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient point of care. The PRP can be mixed with autograft and allograft bone prior to the application to an orthopedic surgical site as deemed necessary by the clinical use requirements.
Selphyl System
The Selphyl System is available in two presentations:
1. Selphyl kit to prepare 4cc of PRFM
2. Selphyl kit to prepare 8cc of PRFM
Additional formats: Gel and membrane
