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FDA OKs Cytori's updated Puregraft for fat grafting

Article-FDA OKs Cytori's updated Puregraft for fat grafting

San Diego — Cytori Therapeutics, based here, announced last week that the Food and Drug Administration has approved an upgraded version of Cytori’s Puregraft technology for use in fat-reduction surgeries.

Reuters reports that the device, the Puregraft 850, had already been approved in Europe. According to Cytori, the device provides processing of up to 850 mL of tissue — a substantially larger volume than the original system. The first system, Puregraft 250, was approved in the United States in 2010.

According to an Associated Press story, Cytori has attracted attention from analysts for another device, called the Celution system, which some plastic surgeons have reportedly used to create fat grafts enhanced with adult stem cells. Some plastic surgeons claim the so-called “stem cell facelift” creates a younger, healthier look, but there are few studies to support such claims, and the FDA has not approved any therapies using stem cells for cosmetic use, the AP reports.

Cytori does not market its products in the United States for use with stem cells. The company recently received FDA approval to begin a small study using Celution system-derived stem cells to treat heart disease, but has no U.S. studies of the device for cosmetic use. Cytori is still able to sell its device to U.S. doctors as laboratory equipment, which the FDA does not regulate.

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