Crux Biomedical’s IVC Filter Receives CE Mark Approval

Crux Biomedical has received CE mark approval for its inferior vena cava filter (IVCF) with bi-directional retrieval. Inferior vena cava filters are implanted to trap blood clots that may cause pulmonary embolism in patients who are at high risk but have contraindications to anticoagulation.

The Crux Biomedical IVCF was designed to overcome several limitations of currently available vena cava filters including perforation, migration and inability to retrieve. Features, from the product page:

  • Self-centering – no-tilt symmetrical spiral design centers filter automatically in vessel lumen
  • Bi-directional deployment and retrieval. Twice the retrieval options of other filters. Designed for either jugular or femoral deployment, and retrieval
  • Atraumatic design goal – Tissue anchor lengths optimized for efficient vessel fixation while limiting perforation
  • Total trans-luminal filtration design provides filtration across the entire lumen of the vessel
  • Controlled filter placement via preloaded, low profile, over-the-wire delivery system

MENLO PARK, Calif., Jan. 23, 2012 /PRNewswire/ – Crux Biomedical announced it has received CE mark approval for their revolutionary inferior vena cava filter (IVCF) with bi-directional retrieval (BDR).  Vena cava filters are designed to trap blood clots that can lead to a potentially fatal pulmonary embolism (PE).  Each year in the United States, approximately 600,000 patients develop a PE and an estimated 200,000 deaths occur.

The Crux Biomedical IVCF was designed to address the limitations of currently available vena cava filters including perforation, migration and inability to retrieve. “Crux was able to design a device that is both more versatile and simple to use,” stated Tom Fogarty, M.D., noted cardiovascular surgeon and founder of Crux Biomedical.

“We are extremely pleased with the results from the recently completed pivotal trial performed at  22 centers of excellence in the United States, Australia, New Zealand and Belgium. Our device demonstrated an excellent safety profile. The Crux device could be retrieved with a 98% success rate,” stated Mel Schatz, CEO of Crux Biomedical. The Company anticipates submission to the FDA in January and U.S. approval in 2012.

Crux Biomedical is located in Menlo Park, California and is focused on developing improved therapies for the human vasculature. It is funded by Alloy Ventures, Three Arch Partners, Emergent Medical Partners and Thomas Fogarty, M.D.. Additional information is available at www.cruxbiomedical.com.

Source:http://www.prnewswire.com/news-releases/crux-biomedicals-ivc-filter-receives-ce-mark-approval-137876098.html

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