FDA clears Crux filter for pulmonary embolism prevention

Source: Crux Biomedical

Crux Biomedical’s vena cava filter has received FDA clearance for the prevention of recurrent pulmonary embolisms.

The Crux vena cava filter is designed to trap blood clots that can lead to potentially fatal pulmonary embolisms among at-risk patients by facilitating bi-directional retrieval through either the femoral or jugular veins.

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.

Vena cava filters provide an alternate treatment for these patients. The small filters are placed in the inferior vena cava to prevent blood clots from reaching the lungs. The FDA has recommended that physicians routinely remove vena cava filters after the risk of pulmonary embolisms is reduced, to avoid long-term complications.

The Crux vena cava filter has received CE Mark approval for commercial use in the European Union.

Results from the RETRIEVE clinical study presented March 25 at the 2012 Society for Interventional Radiology meeting showed technical success rates for the filter deployment and retrieval of 98 percent for both. The average retrieval time was seven minutes, according to Menlo Park, Calif.-based Crux. At the six-month follow up, no embolizations, migrations or fractures were observed.

The prospective, single-arm study recruited 125 patients at high risk for pulmonary embolisms at 22 sites in the U.S., Australia, New Zealand and Belgium to assess the safety, performance and efficacy of the Crux vena cava filter system.