Crux Biomedical announced it has received CE mark approval for their inferior vena cava filter (IVCF) with bi-directional retrieval (BDR).
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, founder of Crux Biomedical.
“We are extremely pleased with the results from the recently completed pivotal trial performed at 22 centres 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, Crux Biomedical. The Company anticipates submission to the FDA in January and US approval in 2012.