A recently completed pivotal trial consisting of 125 patients at high risk for pulmonary embolisms, called the RETRIEVE Clinical Study, was performed at 22 sites in the U.S., Australia, New Zealand and Belgium. The study results were presented at the 2012 Society for Interventional Radiology (SIR) meeting.
In the study, the technical success rate of filter deployment was 98 percent; filter retrieval success was also 98 percent. The average retrieval time was 7 minutes. By the 6-month follow up of the study, no embolizations, migrations or fractures were observed.
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"The Crux device demonstrated excellent deployment, retrieval and safety profile," stated Robert R. Mendes, M.D., Principal Investigator of the study; Associate Professor of Surgery, University of North Carolina; and Chief of Vascular Surgery, Rex UNC Healthcare. "The clinical study evaluation has demonstrated the Crux VCF can be used safely for the prevention of recurrent pulmonary embolisms."
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.
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