Cook Celect IVC Filter
The Cook Celect IVC Filter is an optionally-retrievable IVC filter with four anchoring struts for fixation and eight independent secondary struts to enhance centering and clot trapping.
The Cook Celect IVC filter was first introduced in 2008 after receiving 510(k) clearance from the FDA. FDA 510(k) clearance permits a manufacturer to market a medical device quicker and without the necessity of a more in-depth premarket approval (PMA). To qualify for 510(k) clearance, the new medical device must be “substantially equivalent” to an already approved medical device. In the case of the Cook Celect IVC filter, the substantially equivalent product was the Cook Gunther Tulip IVC filter and so the Cook Celect IVC filter went to market without formal review for the safety and efficacy of the device.
Studies of the Cook Celect IVC filter have shown multiple problems. In short, the filter cannot withstand the normal anatomical and physiological loading cycles exerted in the body as blood is circulated to and from the heart. A study of Gunther Tulip and Celect IVC filters implanted from 2007 to 2009 showed 100% of the Celect and Gunther Tulip IVC filters had some degree of filter perforation of the vein wall within 71 days after surgery. The same study showed that 40% of the Celect and Gunther Tulip IVC filters were out of position or tilted.