Volcano Corporation, a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced the commercial release and initial implantations of its innovative Crux@Vena Cava Filter (VCF) in patients at risk for recurrent pulmonary embolism (PE). It is the only filter with a double helical design that self-centers to help prevent filter tilt and offers the Bi-TrievalT option of retrieval via either the jugular or femoral vein.
The first U.S. implantations of the Crux VCF were performed by:
-- Jeffrey D. Girardot, M.D., chairman of the Department of Radiology at Edward Hospital & Health Services in Naperville, IL
-- Raghava Gollapudi, M.D., interventional cardiologist at Sharp Memorial Hospital in San Diego, CA
-- Donald Jacobs, M.D., chairman of the Department of Surgery at Saint Louis University School of Medicine in St Louis, MO
-- David W. Trost, M.D., associate professor of Clinical Radiology and director of Interventional Radiology at the Weill Medical College of Cornell University in New York, NY
"The Crux VCF is an important development in the prevention of recurrent PE. It was designed to address several limitations associated with filters to date, including the central problem of filter tilt, which can make device retrieval challenging, as well as migration of the filter to other areas of the body, and penetration through the wall of the inferior vena cava," said Dr. Girardot. "The design also allows for retrieval of the filter through either the femoral or jugular vein. This is a particularly beneficial feature in today's healthcare environment, where there is an increased clinical focus on removing filters from patients when the risk of PE has been effectively reduced."
PE, which is caused by migration of a large blood clot arising from the deep veins of the legs, a condition known as deep vein thrombosis (DVT), affects approximately 600,000 patients and results in an estimated 200,000 deaths annually in the United States.i Filters that are implanted in the inferior vena cava (IVC), the large vein that carries de-oxygenated blood from the lower half of the body into the right atrium of the heart, are an important tool in helping prevent potentially deadly PE in patients for whom anticoagulation is contraindicated or ineffective.
"Study data regarding the Crux VCF suggests that it is very successful in addressing the problem of filter tilt commonly associated with other commercially available IVC filter technologies. Filter tilt is a main reason why filter retrieval has proven challenging, given that the hook is often embedded into the vena cava wall," said Dr. Gollapudi.
The U.S. Food and Drug Administration (FDA) recommends that removal of an IVC filter be considered as soon as protection for PE is no longer necessary, and as soon as the removal of the filter is both feasible and clinically indicated.ii Published literature documents a retrieval rate of only 20 to 50 percent, with a mean retrieval rate of approximately 34 percent.iii Prolonged filter retention is associated with adverse events, including filter fracture, filter migration, filter embolization and IVC perforation.ii
"We worked for many years to develop the Crux VCF, and I am thrilled that it is now on the market in the United States, where we believe it can make a difference in reducing risk for recurrent PE, which is often fatal," said Thomas Fogarty, M.D., an internationally renowned cardiovascular surgeon and founder of Crux Biomedical, which developed the Crux VCF and was acquired by Volcano in late 2012. "The Crux VCF represents the first major design innovation for IVC filters in decades. Its unique self-centering design addresses the risks of migration and tilt, provides filtration across the entire lumen of the vessel, and provides for the Bi-TrievalT option of either femoral or jugular retrieval."
"The Crux VCF is a cutting-edge therapy that meets an identified clinical need to improve the rate of IVC filter retrievals," said Neil Hattangadi, M.D., vice president and general manager of Volcano's Peripheral Vascular Business Unit. "This milestone represents one of many recent developments at Volcano that demonstrates the company's commitment to expanding our peripheral product offering and building on our heritage in diagnostics to deliver new therapeutic solutions for the patients and physicians we serve." About the Crux Vena Cava Filter The Crux Vena Cava Filter is designed as a non-conical, double helix.
This double helical, symmetrical design helps prevent filter tilt, as the helical design self-centers automatically within the vena cava upon deployment. It is the only IVC filter that accommodates a bi-directional approach for both deployment and retrieval.iii The safety and effectiveness of the Crux VCF was evaluated in the RETRIEVE 2, 3 and 4 pivotal clinical trials, which enrolled 125 patients at high risk for PE across 22 global sites.iv Results demonstrated high rates of both successful filter deployment (98 percent) and retrieval (98 percent). The mean time for filter deployment was 5 minutes, and the mean time for filter retrieval was 7 minutes, with the approach occurring by femoral access in 85 percent of deployment cases and 70 percent of retrieval cases. Results also showed high rates of safety and effectiveness, with 0 percent embolization, migration (>2cm per SIR guidelines) and filter fracture or filter tilting, and no device-related adverse events requiring intervention reported.
i American Public Health Association. Deep-Vein Thrombosis: Advancing Awareness to Protect Patient Lives. White Paper. Public Health Leadership Conference on Deep-Vein Thrombosis, Washington, D.C., February 26, 2003. http://www.apha.org/NR/rdonlyres/A209F84A-7C0E-4761-9ECF-61D22E1E11F7/0/DVT_White_Paper.pdf. Accessed November 8, 2013.
ii U.S. Food and Drug Administration. Safety Alerts for Human Medical Products. August 2010.
iii Ni H, et al. Retrievable inferior vena cava filters for venous thromboembolism. ISRNRadiology. 2013; Article ID 959452:1-8.
iv Smouse HB, et al. The RETRIEVE Trial: Safety and effectiveness of the retrievable Crux Vena Cava Filter. J Vasc Interv Radiol. 2013; 24:609-62.