Cytori Therapeutics Inc. has received 510(k) clearance from the FDA for a new version of its Puregraft system. The device removes unwanted fluid, blood cells and debris from the fat and prepares it for grafting.
The Puregraft 850 product line extension provides sterile processing of up to 850 mL of tissue, a significantly larger volume than the Puregraft 250.
This device is separate from the Celution system, which some plastic surgeons have used to create fat grafts enhanced with adult stem cells. The FDA has not approved any therapies using stem cells for cosmetic use. Cytori does not market its products in the U.S. for use with stem cells.
Source: press release
