Crux Biomedical has obtained the US Food and Drug Administration (FDA) approval for its bi-directional retrieval inferior vena cava filter (VCF), designed to trap blood clots leading to fatal pulmonary embolisms.
The helical shape of VCF is designed to self-center, reduce bends and stress that can compromise filter integrity and conform more closely to the shape of the device.
The approval is based on pivotal RETRIEVE trial which enrolled 125 patients at high risk for pulmonary embolisms over 22 sites in the US, Australia, New Zealand and Belgium.
The study results demonstrated technical success rate of filter deployment and filter retrieval success of 98%, while the average retrieval time of 7 minutes.
No embolizations, migrations or fractures were observed by the 6-month follow up of the study, according to the company.
Crux Biomedical founder and cardiovascular surgeon Tom Fogarty 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.
Rex UNC Healthcare vascular surgery chief, University of North Carolina associate professor of surgery and study principal investigator, Robert R. Mendes said, "The clinical study evaluation has demonstrated the Crux VCF can be used safely for the prevention of recurrent pulmonary embolisms."
