FDA approves trial of Celution System (Cytori Therapeutics) for CMI

Cytori Therapeutics has received an Investigational Device Exemption (IDE) approval from the FDA to begin the ATHENA trial using its Celution System. ATHENA will investigate the use of the Celution System to treat a form of Coronary Heart Disease, Chronic Myocardial Ischemia (CMI). The IDE application was originally submitted to the FDA in December 2011. The trial will enroll up to 45 patients with no-option CMI who have limited therapeutic options. It will evaluate a variety of clinical and functional outcomes, including safety, peak oxygen consumption (mVO2), and clinical outcomes at 12-months.