January 22, 2012

Crux Biomedical's IVC Filter Approved in Europe

January 23, 2012—Crux Biomedical Inc. (Menlo Park, CA) announced CE Mark approval for its inferior vena cava (IVC) filter in Europe. The Crux device, which features bidirectional retrieval, was designed to capture thrombus for the prevention of pulmonary embolism.

According to the company, the device's design seeks to address problems observed in the past with IVC filters, including perforation, migration, and an inability to retrieve the device. Crux Biomedical noted that in the recently completed pivotal trial performed at 22 centers of excellence in the United States, Australia, New Zealand, and Belgium, the device demonstrated that it could be retrieved with a 98% success rate and showed an excellent safety profile. The company anticipates that the device will be submitted to the US Food and Drug Administration in January and will gain approval in 2012.

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January 22, 2012

Crux Biomedical's IVC Filter Approved in Europe

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