The US Food and Drug Administration (FDA) has cleared Crux Biomedical's bi-directional retrieval inferior vena cava filter (VCF), designed to trap blood clots which lead to fatal pulmonary embolisms.
The helical shape of the VCF is designed to self-centre and reduce bends and stress which can compromise filter integrity and conform more closely to the shape of the device.
The approval was based on the pivotal RETRIEVE trial, which enrolled 125 patients at high risk from pulmonary embolisms at 22 sites in the US, Australia, New Zealand and Belgium.
The study results demonstrated a technical success rate of filter deployment and filter retrieval success of 98%, with the average retrieval time of seven minutes.
No embolisations, migrations or fractures were observed by the six-month follow up of the study, according to the company.
Tom Fogarty, Crux Biomedical founder and cardiovascular surgeon, said bi-directional deployment and retrieval are helpful in situations where access to either the femoral or jugular vein is not possible.
"The Crux VCF with its innovative design and materials represents a paradigm shift in prevention of pulmonary embolisms in patients at risk," Fogarty added.
To avoid long-term complications, the FDA recommended physicians remove the VCF after the risk of pulmonary embolisms is reduced.
Robert R. Mendes, study principal investigator, Rex UNC Healthcare vascular surgery chief and University of North Carolina associate professor of surgery, said the Crux device demonstrated excellent deployment, retrieval and safety profile.
"The clinical study evaluation has demonstrated the Crux VCF can be used safely for the prevention of recurrent pulmonary embolisms," Mendes added.
Image: Bi-directional retrieval traps blood clots where access to either the femoral or jugular vein is not possible. Photo: Crux Biomedical Inc.