Cytori Therapeutics of San Diego, CA has been awarded CE approval to market the PureGraft 250/PURE System in the European Union. The approved system compliments the Celution 800/CRS, and is used in the optimization of graft tissue for autologous fat grafting procedures. The PureGraft 250/PURE System was FDA approved in January of this year, and received a Canadian medical device license in March.
From the press release:
The PureGraft(TM) System sets a new standard for fat graft processing with its membrane-based tissue filtration combined with speed, simplicity, safety and precision. The PureGraft(TM) technology takes only 15 minutes to purify a fat graft ranging from 50 to 250 mL, removing excess and unwanted fluid, lipid, blood cells and debris in a controllable manner. The consumable-based system, used within the sterile field, “dialyzes” off everything but the purified fat tissue without centrifugation or other methods. The ease of use and simplicity of this innovative system sets it apart from other traditional fat grafting methods.