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FDA Clears Novel Vena Cava Filter for Prevention of Pulmonary Embolisms
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A vena cava filter featuring a helical design and bidirectional retrieval has been cleared by the FDA for the prevention of pulmonary embolisms in high-risk patients.
According to a press release, the vena cava filter (VCF; Crux, Crux Biomedical) has a helical design that self-centers, in contrast to the standard “tent” shape filters, which allows it to conform more closely to the shape of the vena cava and leads to reductions in bends and stress that may compromise filter integrity. The VCF also has retrieval hooks and is the first to offer bidirectional retrieval through either the femoral or jugular veins.
The clearance of this VCF follows shortly after the results of the RETRIEVE pivotal trial were presented at the Society for Interventional Radiology meeting in March, which indicated a success rate of filter deployment with the device of 98% and a filter retrieval success rate also of 98% along with an average retrieval time of 7 minutes. No embolizations, migrations or fractures were reported at the 6-month follow-up. The study included 125 patients who were at high risk for pulmonary embolisms from 22 sites in the United States, Australia, New Zealand and Belgium.
Perspective
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Anthony Comerota, MD
This VCF device may potentially have a meaningful impact on clinical practice in that it will affect both patients who need temporary and permanent protection. The filter, on the basis of what we know so far, does not tilt, which is a problem with conical filters. Tilting makes retrieval much more difficult and causes the filter to lose its filtering efficiency, resulting in a decreased capacity for efficient protection. The filter also does not penetrate the vena cava wall, as many do, which would make retrieval more difficult. Furthermore, there is the added benefit of bidirectional retrieval, which allows it to be removed from the jugular or femoral vein fairly easily. The filtering capacity of this device also looks very good.
The data presented to the FDA were the results of its use in 125 consecutive patients. These patients were carefully studied and the results presented. A manuscript is currently under consideration for a peer-reviewed publication. Although the initial data look very good, it is a small patient sample. While I expect similar observations when the filter is used more broadly, this, of course, remains to be seen.
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