WASHINGTON (dpa-AFX) - Cytori (CYTX) said it has received 510(k) clearance from the U.S. Food and Drug Administration or 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, that received a 510(k) in January 2010.
The company noted that larger tissue volumes expand the range of soft tissue procedures for which the product line may be used.
The Puregraft products standardize the preparation of fat grafts, and the 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 would soon be introduced in both the EU and US.
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