Crux Biomedical receives U.S. patent for its novel vena cava filter

Crux Biomedical Inc. announced today that it was awarded a U.S. patent, (US 7,582,100 B2), for its novel vena cava filter. The filter, which is designed to trap blood clots that can lead to a potentially fatal pulmonary embolism (PE), is expected to enter the clinical evaluation phase in the U.S. in the next few months. "We are very pleased with the issuance of this comprehensive patent. The Crux technology is applicable for a breadth of applications to the human vasculature", stated Mel Schatz, CEO of Crux Biomedical.

First introduced in the late 1960's, vena cava filters have become an increasingly important tool in the effort to reduce the occurrence of a PE. There are an estimated 200,000 to 300,000 deaths attributed to PE in the U.S. each year. The American Public Health Association and the CDC have pointed out that deaths attributed to PE exceed the combined deaths per annum in the U.S. due to breast cancer, AIDS and highway fatalities. Experts cite the increase in PE incidence to more complex surgeries, trauma cases, expanded air travel and an overall aging of the population.

Vena cava filters were originally designed as a permanent implant . Over the last decade, design improvements have permitted physicians the choice to either leave a filter in place on a permanent basis or retrieve the filter once a patient is no longer at risk of a PE. Currently in the United States, over 50% of all vena cava filters implanted are designed to be retrieved.

While the vast majority of filters provide effective prevention from a pulmonary embolism, currently approved devices are subject to a variety of complications. " Filter tilt and adherence to the vessel wall present a significant obstacle to filter retrieval. The Crux IVC filter is designed to center itself in the vessel to minimize these difficulties. In addition its design permits for bi-directional retrieval from either the jugular or femoral veins," said Crux V.P. of R&D, Eric Johnson. A bi-directional device affords the physician more flexibility when access to a vessel is compromised in selected patients. The Company anticipates initiating its RETRIEVE II U.S. clinical trial in late 2009 at 18 centers of excellence.