Crux Biomedical's IVC Filter Receives CE Mark Approval


January 27, 2012

January 27, 2012 — Crux Biomedical announced it received CE mark approval for its 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," said Tom Fogarty, M.D., 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 percent success rate," stated Mel Schatz, CEO of Crux Biomedical. The company anticipates submission to the U.S. Food and Drug Administration (FDA) in January and approval in 2012.

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