Crux Biomedical announced it has received FDA clearance for its new Crux Vena Cava Filter (VCF), which Crux Biomedical claims is the first and only VCF designed to facilitate bi-directional retrieval through either the femoral or jugular veins, a key consideration when access to one or the other vein is limited.
VCF are designed to trap blood clots and prevent pulmonary embolisms among patients at risk.
The Crux Vena Cava Filter’s novel helical shape was designed to self-center and to conform more closely to the shape of the vena cava, as well as to reduce bends and stress that can compromise filter integrity.
In a recent study with 125 patients at high risk for pulmonary embolisms, the technical success rate of deployment for the Crux Vena Cava Filter was 98 percent; filter retrieval success was also 98 percent. The average retrieval time was 7 minutes.
By the 6-month follow up of the study, no embolizations, migrations or fractures were observed.