Cosmetic Surgery Today

Plastic Surgery News, Costs of Cosmetic Surgery and Elective Procedures Blog

Cytori Receives FDA Approval for PureGraft System

Posted by Cosmetic Surgery Review on January 13, 2010

Cytori Therapeutics, Incorporated is one of several pharmaceutical and medical companies that has been experimenting with the idea of using a patient’s own fat for certain anti-aging and skin rejuvenation procedures.

Fat injections can be the best solution for some people that want to get rid of wrinkles without surgery, but there has been a lot of controversy over whether this is indeed a safe process.

Cytori has now received approval from the U.S. Food and Drug Administration to sell a device in the United States that uses a patient’s own fat for cosmetic purposes. Cytori’s PureGraft system allows a physician to harvest a patient’s fat for about 15 minutes before re-injecting it into another part of the body. This may help reduce surgery time for certain procedures, and also reduce the amount of dead cells that accompany the fat extraction process.

The PureGraft device is capable of handling both small and large volumes of fat ranging from 50ml to 250ml, and helps to keep the cells sterile before re-injection. The PureGraft system washes the graft and drains all of the tumescent fluid in the treatment site, making the entire process much safer and more efficient.

According to Marc H. Hedrick, M.D., President of Cytori Therapeutics, “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.”

The company reports that more than 46,000 fat-grafting procedures were performed in the United States last year, and that there is now a greater demand for cosmetic procedures that require the use of a patient’s own fat cells to achieve the best possible results.

After receiving FDA approval, shares of Cytori Therapeutics, Incorporated rose 19%. The company will begin working on gaining market approval for the PureGraft system in Europe later this year, and the product will be available in the United States by the end of the first quarter of 2010.


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