Cytori’s PureGraft receives EU approval for fat grafting procedures
17 August 2010
Cytori Therapeutics (NASDAQ: CYTX) has received European (CE Mark) approval for the PureGraft 250/PURE System for autologous fat grafting procedures. It is aimed at the cosmetic and reconstructive surgery market.
PureGraft will be sold as both a standalone product and as a complement to Cytori’s Celution 800/CRS System in Europe.
PureGraft replaces current non-standardized methods of graft preparation. Used independently, PureGraft rapidly and reliably produces optimal graft tissue for use in autologous fat grafting procedures. In combination with the Celution 800/CRS, PureGraft lowers processing times and increases processing volumes, improving the utility and efficiency of Cytori’s core product for soft tissue applications.
“The addition of PureGraft to our product portfolio allows us to offer a broad spectrum of autologous fat grafting technologies in Europe. In addition to Celution System, which enables cell-enriched fat grafting procedures, PureGraft fulfills the need for high quality, sterile tissue for fat grafting procedures, including body contouring,” said Eric Daniels, MD, Cytori’s Managing Director in Europe and the Middle East.
Cytori will immediately begin commercializing PureGraft in Europe, through a combination of direct sales and distributors. In addition to the 27 countries of the EU, the CE Mark is followed by eight other countries and facilitates additional registrations around the world.
The system takes 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 sets it apart from other traditional fat grafting methods.
The PureGraft 250/PURE System received 510(k) marketing clearance for aesthetic body contouring from the US FDA in January of this year. In addition, Cytori received a Canadian medical device license for PureGraft in March 2010.