Cytori (CYTX) receives 510(k) Clearance for Puregraft(R) 850
CYTX has received 510(k) clearance from the FDA for the Puregraft(R) 850 System for body contouring using a patient’s own fat.
The Puregraft(R) 850 product line extension provides optimized and sterile processing of up to 850 mL of tissue, a significantly larger volume than the Puregraft(R) 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(R) products are best-in-class innovative products which standardize the preparation of fat grafts. Puregraft(R) 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.
- According to the American Society of Plastic Surgeons’ most recent report, more than 57,000 fat grafting procedures were performed in theUnited Statesin 2010, a 14% increase over the previous year.
The Bottom Line: A very good indicator for CYTX and the RegMed universe to keep the universe in the news. The Puregraft(R) 850 System has also received European approval and will soon be launched in both the EU and US.
The Puregraft(R) technology is the standard for fat graft processing with its membrane-based tissue filtration combined with speed, simplicity, safety and precision. The Puregraft(R) technology takes approximately 15 minutes to purify a fat graft ranging from 50 to 850 mL, removing excess and unwanted fluid, lipid, blood cells and debris in a controllable manner. The single use system, used within the sterile field, purifies fat tissue without centrifugation or other methods. The ease of use and simplicity of this innovative system sets it apart from other traditional fat grafting methods.
