FDA Clears First Bi-Directionally Retrievable Vena Cava Filter
Crux Biomedical received U.S. Food and Drug Administration (FDA) clearance for its novel inferior vena cava filter (VCF) with bi-directional retrieval in July 2012. VCF are designed to trap blood clots that can lead to potentially fatal pulmonary embolisms among patients at risk. The Crux VCF 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. The device’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.
Each year in the United States, approximately 600,000 patients develop pulmonary embolisms, and an estimated 200,000 deaths occur. The primary means of prevention and therapy for pulmonary embolisms is systemic administration of anticoagulant agents. However, this treatment is contraindicated in many patients, including those with high bleeding risk, those undergoing complex surgeries and patients for whom anticoagulants were ineffective.
Patients in whom anticoagulant treatment is contraindicated require alternate treatments to reduce the ongoing pulmonary embolism risk, including VCF. The FDA has recommended that physicians routinely remove VCF after the risk of pulmonary embolisms is reduced to avoid long-term complications.
A completed pivotal trial consisting of 125 patients at high risk for pulmonary embolisms, called RETRIEVE, was performed at 22 sites in the U.S., Australia, New Zealand and Belgium. The study results were presented at the 2012 Society for Interventional Radiology (SIR) meeting.
In the study, the technical success rate of filter deployment was 98 percent; filter retrieval success was also 98 percent. The average retrieval time was 7 minutes. By the six-month follow-up, no embolizations, migrations or fractures were observed.
For more information: www.cruxbiomedical.com