MENLO PARK, Calif. /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.
