MAGELLAN Indications For Use And Disclaimer

Indications For Use

The Magellan® Autologous Platelet Separator System is designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood or a small mixture of blood and bone marrow. The plasma and concentrated platelets produced can be used for diagnostic tests. Additionally, the platelet rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic site as deemed necessary by the clinical use requirements.

Disclaimer

The platelet rich plasma prepared by this device has not been evaluated for any clinical indications. Platelet rich plasma prepared from a mixture of whole blood and bone marrow may contain higher levels of plasma free hemoglobin than platelet rich plasma prepared from whole blood.