Results from the recently completed RETRIEVE pivotal trial for the Crux Vena Cava Filter (VCF) System (Crux Biomedical) were presented by Robert R Mendes, principal investigator of the study, at the Society of Interventional Radiology (SIR) Annual Scientific Meeting (March 24–29, San Francisco, USA). In the study, the technical success rate of filter deployment was 98% and filter retrieval success was also 98%.
“The Crux device demonstrated an excellent safety profile,” said Mendes, associate professor of surgery, University of North Carolina and chief of Vascular Surgery, Rex UNC Healthcare. “The clinical study evaluation has demonstrated the Crux VCF System device can be used safely for the prevention of recurrent pulmonary embolism.”
The RETRIEVE clinical trial was a prospective, single-arm, multinational investigational study to assess the safety, performance, and efficacy of the Crux VCF System as both a retrievable and a permanent device. The trial included 125 patients at high risk for pulmonary embolism and was performed at 22 centres in the United States, Australia, New Zealand and Belgium.
In the study, the technical success rate of filter deployment was 98% and filter retrieval success was also 98%. The average retrieval time was 7 minutes, with the femoral approach used for retrieval in 70% of cases. By the 6-month follow up of the study (CONFIRM), no embolizations, migrations, or fractures were observed.
The Crux Biomedical VCF was designed to address the limitations of currently available vena cava filters, including perforation, migration and inability to retrieve. “Crux designed a device that is both more versatile and simple to use,” said Tom Fogarty, cardiovascular surgeon and founder of Crux Biomedical.
The Crux VCF has CE mark approval for commercial use in the European Union. The System is being studied in the United States under an approved investigational device exemption study. FDA 510(k) clearance for commercial distribution in the USA is pending.
