WASHINGTON (dpa-AFX) - Medical products and devices company Cytori Therapeutics Inc. (CYTX) said Monday that it received an Investigational Device Exemption or IDE approval from the U.S. FDA to begin the Athena trial. According to the company, Athena trial, a multi-center, randomized, double blind, placebo controlled, pilot trial wil investigate the use of autologous, clinical-grade adipose-derived stem and regenerative cells or ADRCs, processed at the point-of-care with its proprietary Celution System. The system is used to treat a form of coronary heart disease, chronic myocardial ischemia. The trial will enroll up to 45 patients with no-option CMI who have limited therapeutic options. In the U.S., it is estimated that 120,000 to 250,000 patients are diagnosed each year with chronic myocardial ischemia.
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