Volcano Announces First Commercial Implantations of Crux Vena Cava Filter

November 13, 2013—Volcano Corporation (San Diego, CA) announced the commercial release and initial implantations of its Crux vena cava filter (VCF) in patients at risk for recurrent pulmonary embolism (PE). The Crux filter features a nonconical, double-helical design that self-centers to help prevent filter tilt and provides the company's Bi-Trieval option of retrieval via either the jugular or femoral vein. It accommodates a bidirectional approach for both deployment and retrieval.

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. In May 2013, H. Bob Smouse, MD, et al published the RETRIEVE trial's safety and effectiveness data for the Crux VCF in the Journal of Vascular and Interventional Radiology (2013;24:609–621).

The company stated that the results demonstrated high rates of both successful filter deployment (98%) and retrieval (98%). 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% of deployment cases and 70% of retrieval cases. Results also showed high rates of safety and effectiveness, with 0% embolization, migration (> 2 cm per SIR guidelines), and filter fracture or tilting, as well as no device-related adverse events requiring intervention reported.

In the United States, the first implantations of the Crux VCF were performed by Jeffrey D. Girardot, MD; Raghava Gollapudi, MD; Donald Jacobs, MD; and David W. Trost. Dr. Girardot, who is Chairman of the Department of Radiology at Edward Hospital & Health Services in Naperville, Illinois, and Dr. Gollapudi, who is an interventional cardiologist at Sharp Memorial Hospital in San Diego, California, discussed the new device in the company's press release.

Dr. Girardot commented, “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. 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 health care environment, where there is an increased clinical focus on removing filters from patients when the risk of PE has been effectively reduced.”

Dr. Gollapudi added, “Study data regarding the Crux VCF suggest 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.”

Founded by Thomas Fogarty, MD, Crux Biomedical developed the Crux VCF and was acquired by Volcano in late 2012.