FDA GRANTS CYTORI 510(K) CLEARANCE FOR PUREGRAFT(R) 850 SAN DIEGO, CA -- (MARKET WIRE) -- 03/16/12 -- Cytori (NASDAQ: CYTX) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Puregraft® 850 System for body contouring using a patient's own fat. The Puregraft® 850 product line extension provides optimized and sterile processing of up to 850 mL of tissue, a significantly larger volume than the Puregraft® 250, which received a 510(k) in January 2010. Larger tissue volumes expand the range of soft tissue procedures for which the product line may be used.
The Puregraft® products are best-in-class innovative products which standardize the preparation of fat grafts. Puregraft® technology has been rapidly adopted since the original launch in 2010. Fat grafting is an important trend in reconstructive and aesthetic surgery, with broad applications in soft tissue procedures. The Puregraft® 850 System has also received European approval and will soon be launched in both the EU and US.
According to the American Society of Plastic Surgeons' most recent report, more than 57,000 fat grafting procedures were performed in the United States in 2010, a 14% increase over the previous year.