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.
A new study reveals a brand of IVC filter — a small, metal cage-like device used to prevent blood clots from entering the lungs — poses a significant risk of puncturing a major blood vessel.
The Cook Celect filter had a 43 percent rate of perforation versus the Option filter, which had a zero percent perforation rate. Study authors noted this was a “significantly higher rate.”
In the study published in June 2015 in the Journal of Vascular Interventional Radiology, researchers looked at the records of 99 people implanted with the Cook Celect IVC filter and 86 patients who received an Option filter sold by Rex Medical. After about two months, doctors retrieved the filters. While surgeons had slightly more difficulty retrieving Option filters from the vein, the difference in the rate of retrieval was negligible.
Researchers were more concerned with a potentially troublesome complication: vena cava perforation. Surgeons place IVC filters in the inferior vena cava, the large vein that carries blood back to the heart. The filters are designed with small prongs called struts that act like a cage for blood clots. Unfortunately, some devices also puncture, or perforate, the vena cava wall.
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.