Purpose
Determine the in-vitro clot capture efficiency (CCE) of an investigational absorbable inferior vena cava filter (IVCF) versus the Greenfield IVCF.
Materials and Methods
Investigational absorbable and Greenfield filters were challenged with polyacrylamide (PAM) clot surrogates ranging from 3×5 to 10×24 mm (dia. × length) in a flow loop simulating the venous system. Filters were challenged with clots until CCE standard error of 5% or less was achieved under binomial statistics. Pressure gradients across the filters were measured for the largest size clot, enabling calculation of forces on the filter.
Results
The absorbable IVCF in-vitro CCE was statistically similar to the Greenfield filter for all clot sizes apart from the 3×10 mm clot, where there was statistically significant difference between filter CCE’s (absorbable filter: 59%, Greenfield: 31%, p=0.0001). CCE ranged from an average 32% for the 3×5 clot to 100% for 7×10 mm and larger clots for the absorbable IVCF. Pressure gradient across the absorbable filter with 10×24 mm clot averaged 0.14 mmHg, corresponding to a net force on the filter of 2.1×10−3 N, compared to 0.39 mmHg or 5.8×10−3 N (p<0.001) for the Greenfield filter.
Conclusions
CCE of the absorbable filter was statistically similar to, or an improvement upon, the Greenfield stainless steel filter for all clot sizes tested. CCE of the Greenfield filter in this study aligned with data from previous studies. Given the efficacy of the Greenfield filter in attenuating the risk of pulmonary embolism, the current study suggests the absorbable filter may be a viable candidate for subsequent human testing.