Cytori Therapeutics today announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to begin the ATHENA trial to investigate the use of the company’s Celution® System.
Cytori develops medical technologies to realize the potential of adult regenerative cells from fatty (adipose) tissue. The Celution® System is an innovative medical device to prepare adipose-derived stem and regenerative cells (ADRCs) to treat chronic myocardial ischemia (CMI), a form of coronary heart disease. The company sells its Celution® System family of medical devices in the European and Asian cosmetic and reconstructive surgery markets. Per today’s news, the device is available in the U.S. as an investigational advice.
“Following our pre-IDE meeting with the FDA, we received constructive guidance and implemented the Agency’s recommendations, ultimately resulting in rapid approval to initiate the ATHENA trial,” Christopher J. Calhoun, CEO for Cytori stated in the press release. “We look forward to working with the FDA on further defining our clinical strategy in the U.S.”
The ATHENA trial will enroll up to 45 patients to evaluate several clinical and functional outcomes, including safety, peak oxygen consumption (mVO2), and clinical outcomes at 12 months.
For more information visit www.cytori.com
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