BioCentury
ARTICLE | Company News

Cytori gene/cell therapy news

April 1, 2013 7:00 AM UTC

The U.S. Court of Appeals for the District of Colombia upheld a 2009 FDA decision that two devices from Cytori will require approval through the PMA pathway rather than a 510(k) application. Cytori was seeking approval of its Celution 700 and StemSource 900 tissue processing systems for use in banking and research as Class 2 medical devices. The court concluded that FDA's determination that Cytori's devices were not "substantially equivalent" to any other marketed product was "reasonable" since the most similar devices extract stem cells from blood or bone marrow. The 510(k) approval pathway requires products to be "substantially equivalent," which requires the product to have the same intended use and technological characteristics as the predicate device. The court agreed with FDA's determination that Cytori's products did not meet either of the requirements.

The company is already seeking approval of the Celution system through the PMA pathway to treat refractory heart failure due to chronic myocardial ischemia and said it would no longer pursue approval in the U.S. for the products for research use. The devices are already approved for research use in Europe and Japan (see BioCentury, March 22, 2010). ...