Celution 700, a device designed by Cytori Therapeutics to fill out soft tissue voids and for body contouring, has recently been cleared to be regulated as a medical device by the United States Food and Drug Administration. This means that Cytori must submit a formal marketing application to the FDA to determine if clinical evaluations will be needed in order for the product to be used in services for the consumer market.
According to Christoper Calhoun, CEO of Cytori, “This important decision provides greater clarity of our regulatory path in the U.S. and is consistent with our interpretation of current device regulations. We are preparing for the next steps in the process of working with the FDA to determine the specific device marketing application to submit, including whether clinical evaluations will be necessary.”
The Celution system harvests adipose tissues, separates the fat cells into a concentrate, and then returns the cells into the patient to begin the reconstruction process. It is designed primarily to promote bone healing and tissue regeneration, and the system is one of the latest advances in reconstructive plastic surgery.
Cytori received a Notice of Allowance from the U.S. Patent and Trademark Office related to the use of the Celution system for treatment bone-related disorders in early July 2009. Other patent claims have been filed, but it the system is now under review by the FDA review boards and committees. According to Cytori’s website, “The Celution® Technology has been developed as the first bedside device to enable real-time, adult stem and regenerative cell processing. This innovative technology automates and standardizes the separation and concentration of a patient’s own (autologous) adult stem and regenerative cells from body fat (adipose) for real-time redelivery to the same patient.”
The FDA’s Center for Biologics Evaluation and Research will conduct further investigations to determine if the device meets all Investigational Device Exemption (IDE) regulations and standards.