Cytori Therapeutics (Cytori) has received 510(k) marketing clearance for its PureGraft System from the FDA. The company is expected to launch the device in the US, cleared for aesthetic body contouring using autologous fat. PureGraft allows a patient's own fat tissue to be prepared in approximately 15 minutes for re-injection back into the same patient for aesthetic contouring.
The company claims that PureGraft is able to prepare both small and large volumes of fat grafting tissue, ranging from 50ml to 250ml. 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.
PureGraft will be sold in the US directly by the company 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.
The company is also seeking marketing approval (CE Mark certification) for PureGraft in Europe, which is expected in the first half of 2010. In Europe, PureGraft will be used to complement the currently available autologous tissue processing system as a means to expand the potential number of clinical applications.
The company said that Celution System family of medical devices and instruments is being sold into the European and Asian cosmetic and reconstructive surgery markets, but is not yet available in the US. The StemSource product line is sold globally for cell banking and research applications.
Marc Hedrick, president of Cytori Therapeutics, said: “FDA clearance provides us with a strategically important product in addition to the CelBrush to help establish our brand and build relationships with US plastic and reconstructive surgeons.
“There are several advantages this product offers physicians performing autologous fat grafts, which can improve efficiencies in the operating room, decrease surgery time and, by being able to process greater volumes, to include large defects.”