What is SELPHYL®?
The patented SELPHYL® System enables the safe and rapid preparation of an activated Platelet-rich Fibrin Matrix (PRFM). A small volume of the patient’s blood is collected and the platelets and fibrin are concentrated during a simple centrifuge process. The resulting product (liquid, gel or membrane) can be applied to a treatment area of the face or body to stimulate natural, new tissue growth. SELPHYL® prepared PRFM has been shown to increase skin volume and rejuvenation.
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.
With over 45,000 procedures performed world-wide, this technology has been extensively used for soft tissue regeneration in plastic surgery, orthopedics and maxillofacial surgery.
Reproducible and easy-to-use 3 step system
The three-step turnkey procedure to prepare SELPHYL® PRFM takes approximately 20 minutes and is performed in your office.
Step 1: A small volume of blood is collected.
First, the patient’s treatment site may be numbed using your preferred local anesthetic. Then 9cc of venous blood is collected in the yellow-stoppered collection tube using the butterfly needle and placed in Aesthetic Factors provided centrifuge.
With a single blood collection of 9cc, four 1cc syringes of PRFM can be prepared – enough for a facial rejuvenation procedure.
Step 2: The patient’s platelets and fibrin are separated and concentrated into PRFM
The yellow-stoppered tube is centrifuged for 6 minutes in our custom centrifuge, pre-programmed for the correct speed and time. The tube is then removed and can be stored at the physician’s convenience under room temperature conditions for up to 2 hours.
Step3: Matrix formation
The blood collection tube (yellow) is inverted ten times to ensure homogeneous dispersion of all active ingredients into the plasma supernatant. The plasma is then transferred to a second tube (with red top) containing a fibrin forming catalyst, using the provided transfer device. This catalyst activates the polymerization of fibrin and platelets into PRFM.
PRFM can be aspirated from the red-top tube into four 1cc syringes (not provided) for application.
Take note: Extensive polymerization of fibrin renders the PRFM too viscous to inject after 10 minutes following the transfer.
SELPHYL® PRFM should be administered using your preferred technique.
Physicians and patients have seen promising and lasting results, with visible effects noted as early as 3 weeks after injection.
Procedure Note: Standard blood collection procedures and universal precautions should be followed when performing the SELPHYL® procedure.
What does PRFM do?
Alpha granules in intact platelets contain many tissue regenerating proteins. In vitro studies have shown that PRFM continues to release these growth and regeneration factors for up to seven days. Several of these factors have been shown to stimulate cell migration, proliferation and differentiation; known to initiate the production of collagen and trigger other biological responses.
The fibrin matrix produced insitu serves to maintain the intact platelets at the site of injection and provide a scaffold for the cells migrating under the influence of the released chemotactic factors.
Growth Factors and Proteins Release from PRFM
A variety of growth factors are produced at a steady rate. Key factors present are bFGF, PDGF-BB, EGF, TGFbeta and VEGF.
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Clinical experience
Glabella lines
Nasolabial folds
Acne scars
Post operative scars
Full Face contouring
Dermal defects
Divots
Regulatory status: FDA cleared Class IIa device (510(k) #BK020051 & BK060006) and CE mark
The SELPHYL® System is manufactured by Cascade Medical Enterprises, LLC, an affiliate of 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 also 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
SELPHYL® – Precautions
Conditions that preclude the use of PRFM include: aspirin ingestion, vitamin-E containing medications, warfarin therapy, sepsis, acute and chronic infections, fibrinogen disorders, very low platelet counts and any coagulation disorders. Facial intradermal injection of PRP may require the use of a topical anesthetic or regional nerve blocks. Ice packs and or analgesics can be used at the physicians discretion.




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