Frequently Asked Questions

Is the Selphyl® System safe?

The Selphyl® System has been shown to be safe, and no allergic reactions have been reported.


How is the treatment with the Selphyl® System performed?

The Selphyl® System is used by a physician for the safe and rapid preparation of autologous PRP using a small amount of a patient's blood. The entire procedure typically occurs in office and takes about 30 minutes.


Are there any side effects?

There have been no known side effects reported to date. However, you may experience some common reactions at the injection site: mild irritation, swelling, bruising, edema, itching, discoloration or tenderness. These are temporary conditions and typically resolve themselves within two days.

There is virtually no risk of allergic reaction and no allergic reactions have been reported to date. The Selphyl® System is used to rapidly collect and isolate a patient's own PRP for injection and contains no animal or synthetic products.

Has the Selphyl® System been reviewed by a regulatory authority?

The Cascade Medical FIBRINET® System was cleared for marketing under premarket notification (510(k)) submission numbers BK020051 and BK060006.  Cascade Medical Enterprises, LLC has entered into a licensing agreement with Aesthetic Factors, LLC whereby Aesthetic Factors, LLC markets the FIBRINET® Autologous Fibrin & Platelet System in the U.S. under the trade name Selphyl®. The CE mark certification has been granted in Europe.

The SELPHYL® System is manufactured by Cascade Medical Enterprises, LLC, and licensed to Aesthetic Factors, LLC.

 

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