Volcano, a developer and manufacturer of precision guided therapy tools, has announced the commercial release and initial implantations of its new Crux vena cava filter (VCF) in patients at risk for recurrent pulmonary embolism (PE).
It is the only filter with a double helical design that self-centers to help prevent filter tilt and offers the Bi-Trieval option of retrieval via either the jugular or femoral vein, the company claims.
The US Food and Drug Administration (FDA) recommends that removal of an IVC filter be considered as soon as protection for PE is no longer necessary, and as soon as the removal of the filter is both feasible and clinically indicated.
Published literature documents a retrieval rate of only 20-50%, with a mean retrieval rate of approximately 34%. Prolonged filter retention is associated with adverse events, including filter fracture, filter migration, filter embolization and IVC perforation.
Crux Biomedical, which developed the Crux VCF and was acquired by Volcano in late 2012, founder Dr Thomas Fogarty noted the company worked for many years to develop the Crux VCF, and it is thrilled that the device is now on the market in the US, where the company believes it can make a difference in reducing risk for recurrent PE, which is often fatal.
"The Crux VCF represents the first major design innovation for IVC filters in decades. Its unique self-centering design addresses the risks of migration and tilt, provides filtration across the entire lumen of the vessel, and provides for the Bi-Trieval™ option of either femoral or jugular retrieval," Dr Fogarty added.