The US Food and Drug Administration (FDA) granted 510(k) clearance for Cytori Therapeutics’ Puregraft 850 System, used to contour a patient’s body using their own fat.
The Puregraft 850 product line provides optimised and sterile processing of up to 850 ml of tissue, a considerably larger volume than the Puregraft 250, which received 510(k) clearance in January 2010.
The Puregraft technology is the standard for fat graft processing with its membrane-based tissue filtration integrated with speed, simplicity, safety and precision, the company said.
Using the single-use, closed, sterile, disposable product, physicians can control the hydration of the graft by varying the drain times and number of wash cycles, reducing the risk of graft contamination during preparation.
The Puregraft technology takes around 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 Puregraft 850 System has also received European approval and will be soon launched in both the European Union and US.
More than 57,000 fat grafting procedures were performed in the US in 2010, a 14% increase over the previous year, according to the American Society of Plastic Surgeons report.
Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects.
Image: Puregraft 850 provides optimised and sterile processing of up to 850 ml of tissue, a larger volume than the Puregraft 250. Photo: FDA.