Abstract
Californian Vascular Company, Crux Biomedical has announced it has received CE mark approval for its revolutionary inferior vena cava filter (IVCF) with bi-directional retrieval (BDR).
Background
Vena Cava Filters are designed to trap blood clots emanating from the peripheral vasculature before they enter the heart and then the lungs, leading to a potentially fatal pulmonary embolism (PE). Each year in the United States, approximately 600,000 patients develop a PE and an estimated 200,000 deaths occur.
Crux Biomedical was founded in 2004 by Cardiovascular surgeon Tom Fogarty, a recognised pioneer in medical device circles.
The Crux Biomedical IVCF was designed to address the limitations of currently available vena cava filters including perforation, migration and inability to retrieve.
Company comments
“Crux was able to design a device that is both more versatile and simple to use,” stated Tom Fogarty, M.D., noted cardiovascular surgeon and founder of Crux Biomedical.
“We are extremely pleased with the results from the recently completed pivotal trial performed at 22 centers 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 of Crux Biomedical.
FDA clearance next?
The Company anticipates submission to the FDA in January and U.S. approval in 2012.
Source: Crux Biomedical Inc
published: January 25, 2012 in: Approval/Clearance, Cardio, Regulatory, Thoracic/Respiratory, Vascular