Plastic surgery fat graft device PureGraft approved in US: Cytori

According to the American Society of Plastic Surgeons’ most recent report of plastic surgery statistics, over 46,000 fat grafting procedures were performed in the United States in 2008. Currently, over 5,000 plastic surgeons are registered with the American Society of Plastic Surgeons.

PureGraft, first and only device in the United States cleared for aesthetic body contouring using autologous fat Cytori Therapeutics, has been granted marketing clearance in US.

PureGraft allows a patient’s own fat tissue to rapidly be prepared in approximately 15 minutes for re-injection back into the same patient for aesthetic contouring.

PureGraft is able to prepare both small and large volumes of fat grafting tissue ranging from 50 mL to 250 mL.

Puregraft maintains sterility while optimizing the yield of tissue to be grafted, which provides significant utility to physicians.

In contrast to traditional methods of graft preparation, PureGraft washes the graft and drains the tumescent fluid, free lipid and debris in a closed sterile system, allowing for a cleaner graft in less time than it would take to prepare a comparable volume of graft tissue traditionally.

“FDA clearance provides us with a strategically important product in addition to the CelBrush to help establish our brand and build relationships with U.S. plastic and reconstructive surgeons,” said Marc H. Hedrick, M.D., President of Cytori Therapeutics.
PureGraft will be sold in the United States directly by Cytori as well as through select distribution partners on a non-exclusive basis. The product will be available in the first quarter of 2010 and will be formally launched at the American Society of Aesthetic Plastic Surgeons in May 2010.

Cytori is also seeking marketing approval (CE Mark certification) for PureGraft in Europe, which is expected in the first half of 2010. In Europe, PureGraft, in addition to being sold as a standalone product, will be used to complement Cytori’s currently available autologous tissue processing system as a means to expand the potential number of clinical applications.

According to the American Society of Plastic Surgeons’ most recent report of plastic surgery statistics, over 46,000 fat grafting procedures were performed in the United States in 2008. Currently, over 5,000 plastic surgeons are registered with the American Society of Plastic Surgeons.