Volcano has announced the commercial release and initial implantations of its innovative Crux vena cava filter in patients at risk for recurrent pulmonary embolism. It is the only filter with a double helical design that self-centres to help prevent filter tilt and offers the Bi-Trieval option of retrieval via either the jugular or femoral vein.
The first US implantations of the Crux vena cava filter were performed by Jeffrey D Girardot, chairman of the Department of Radiology at Edward Hospital & Health Services in Naperville, Raghava Gollapudi, interventional cardiologist at Sharp Memorial Hospital in San Diego, Donald Jacobs, chairman of the Department of Surgery at Saint Louis University School of Medicine in St Louis, David W Trost, associate professor of Clinical Radiology and director of Interventional Radiology at the Weill Medical College of Cornell University in New York.
“The Crux vena cava filter is an important development in the prevention of recurrent pulmonary embolism. 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 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 pulmonary embolism has been effectively reduced.”
“Study data regarding the Crux inferior vena cava filter suggests that it is very successful in addressing the problem of filter tilt commonly associated with other commercially available inferior vena cava 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 Gollapudi.
The FDA recommends that removal of an inferior vena cava filter be considered as soon as protection for pulmonary embolism is no longer necessary, and as soon as the removal of the filter is both feasible and clinically indicated. Published literature documents a retrieval rate of only 20 to 50%, with a mean retrieval rate of approximately 34%. Prolonged filter retention is associated with adverse events, including filter fracture, filter migration, filter embolisation and inferior vena cava perforation.
“We worked for many years to develop the Crux vena cava filter, 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 pulmonary embolism, which is often fatal,” said Thomas Fogarty, an internationally renowned cardiovascular surgeon and founder of Crux Biomedical, which developed the Crux vena cava filter and was acquired by Volcano in late 2012. “The Crux vena cava filter represents the first major design innovation for inferior vena cava filters in decades. Its unique self-centring design addresses the risks of migration and tilt, provides filtration across the entire lumen of the vessel, and provides for the Bi-Trieval option of either femoral or jugular retrieval.”
“The Crux vena cava filter is a cutting-edge therapy that meets an identified clinical need to improve the rate of inferior vena cava filter retrievals,” said Neil Hattangadi, 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.”
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-centres automatically within the vena cava upon deployment. It is the only inferior vena cava filter that accommodates a bidirectional approach for both deployment and retrieval.
The safety and effectiveness of the Crux vena cava filter was evaluated in the RETRIEVE 2, 3 and 4 pivotal clinical trials, which enrolled 125 patients at high risk for pulmonary embolism across 22 global sites. Results demonstrated high rates of both successful filter deployment (98%) and retrieval (98%). The mean time for filter deployment was five minutes, and the mean time for filter retrieval was seven minutes, with the approach occurring by femoral access in 85% of deployment cases and 70% of retrieval cases. Results also showed high rates of safety and effectiveness, with 0% embolisation, migration (>2cm per SIR guidelines) and filter fracture or filter tilting, and no device-related adverse events requiring intervention reported.