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Crux Biomedical Announces First Successful U.S. Implant of Its New Retrievable Inferior Vena Cava (IVC) Filter
Date:10/3/2007

ATLANTA, Oct. 3 /PRNewswire/ -- Crux Biomedical, Inc., a privately held medical device firm, announced that it has successfully completed the first implant in the United States of the Crux IVC Filter. The filter, used to prevent an often fatal pulmonary embolism (PE), was implanted at the Atlanta Medical Center by David Rosenthal, Chief of Vascular Surgery. Every year in the United States, approximately 600,000 patients develop a PE and between 120,000 - 150,000 die as a result. The revolutionary filter design provides unique self-centering, ease of retrieval and low profile.

"The Crux filter was extremely easy to deploy. We are excited with the devices' ability to routinely self center in the vena cava and as result, we anticipate improved retrievability," Rosenthal stated. Atlanta's David Rosenthal is the Principal Investigator for Crux's pivotal IDE study, which is being conducted at 12 leading medical institutions in the United States.

Retrievable IVC filters were first introduced in the United States in 2002. They offer physicians the option to leave the device in on a permanent basis or to remove the filter via minimally invasive methods, once the patient is through the period when they are at risk for a PE. However current retrievable filters offer challenges to physicians. "Tilting of an IVC filter makes subsequent retrieval very challenging and can take up to several hours to accomplish," said Frank Arko, co-founder of Crux and Chief of Endovascular Surgery at University of Texas Southwestern. "I was amazed how easy it was to retrieve the Crux filter in our initial implants outside the United States. We were able to deploy or remove the filter in less than 5 minutes."

Annual sales of IVC filter in the United States are estimated to be $252MM in 2008 and growing between 8-10% annually. Filters are increasingly being used as a result of increased diagnosis of deep vein thrombosis and the protection that they afford in cases of trauma and orthopedic surgeries.

"Crux was able to design a device that is versatile and simple to use," stated Thomas Fogarty, M.D., cardiovascular surgeon and founder of Crux Biomedical. Mel Schatz, CEO of Crux states, "We have had very encouraging results from both our initial implants outside of the United States and feedback from our very experienced U.S. investigators. We are confident that we have developed an IVC filter that better meets the needs of implanting physicians."

Crux Biomedical, headquartered in Portola Valley, California, was founded in late 2004 by Dr. Thomas Fogarty and Dr. Frank Arko. The company is developing an implantable vascular device that offers significant improvement over existing IVC filters. The device has been successfully implanted in humans in international studies and has been granted approval by the FDA to initiate its pivotal IDE study.

For additional information contact Mel Schatz, Crux Biomedical, at (650) 851-2332, ext. 38, or mschatz@cruxbiomedical.com


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SOURCE Crux Biomedical, Inc.
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