The Crux Filter: Paradigm Shift in PE Prevention and IVC Filtration?

Crux Biomedical’s new inferior vena cava filter received 510(k) FDA clearance for U.S. commercialization last month. The device’s novel helical shape was designed to self-center and to conform more closely to the shape of the vena cava, as well as to reduce bends and stress that can compromise filter integrity. Dr. Tom Fogarty is the company founder and a noted cardiovascular surgeon, inventor, and innovator. In describing this development he stated, “Bi-directional deployment and retrieval are extremely helpful in situations where access to either the femoral or jugular vein is not possible. The Crux vena cava filter, with its innovative design and materials, represents a paradigm shift in prevention of pulmonary embolism in patients at risk.”1 Those responsible for the conception of the filter intended to develop a new tool that would address the limitations of currently available vena cava filters, including perforation, migration, and inability to retrieve.

The recently completed pivotal clinical trial (RETRIEVE) consisted of 125 patients at high-risk for pulmonary embolism enrolled at 22 sites in the U.S., Australia, New Zealand, and Belgium. The study results were presented at the 2012 Society for Interventional Radiology meeting. The technical success rate of filter deployment was 98%; filter retrieval success was also 98%. The average retrieval time was 7 minutes. By the 6-month follow-up of the study, no embolizations, migrations, or fractures were observed.

This new filter design and features emerge as very appealing to this writer. It may well fulfill the promise stated by the company founder and represent a true paradigm shift. Time and a much larger clinical experience will tell.

Reference

1. https://www.cxvascular.com/in-latest-news/interventional-news---latest-news/fda-clears-first-ever-bi-directionally-retrievable-vena-cava-filter-from-crux-biomedical