Cytori Therapeutics, a publicly-traded pharmaceutical company, has received the European approval CE mark for an innovative stem cell device. The Celution® System is a unique medical device that extracts and separates stem cells and regenerative cells from the patient’s fat tissue. This process is helpful for fat transfer procedures and can help with breast reconstruction. The Celution System may be very effective for repairing soft tissue defects, facilitating the wound healing process, and also for repairing the effects of Crohn’s disease.
Clinical data from Cytori’s RESTORE 2 breast reconstruction trial in Europe and several other wound repair clinical studies show that the previously-approved indications for use in the Celution® Steym are still active and unchanged. The system can be used to perform a number of different procedures, and may soon be marketed to clinics and hospitals in the United States.
The new indications covering the Celution® System for the digestion of adipose tissue can be used to prepare and implant autologous cell-enriched fat grafts for breast reconstruction procedures, and also deliver the Celution® System cellular output to facilitate healing of rectal and vaginal wounds resulting from Crohn’s disease.
According to Marc H. Hedrick, M.D., president of Cytori, “The expanded indications improve our ability to provide the Celution® System to European hospitals in addition to the private-pay plastic and cosmetic surgery clinics…these claims, coupled with our expanded focus on reimbursement, will make this technology more broadly available, not just for a wider range of procedures but to a greater population of patients.” (Source: MarketWatch.com)
Over 370,000 women are diagnosed with breast cancer in Europe each year and the majority of these patients need to undergo some form of breast reconstruction procedure. The Cytori stem cell device may help many of these women undergo a successful procedure.