Abstract
The Sentry inferior vena cava (IVC) filter is designed to provide temporary protection from pulmonary embolism (PE) and then bioconvert to become incorporated in the vessel wall, leaving a patent IVC lumen. Objective. To evaluate the performance and stages of incorporation of the Sentry IVC filter in an ovine model. Methods. Twenty-four bioconvertible devices and 1 control retrievable filter were implanted in the infrarenal IVC of 25 sheep, with extensive daily monitoring and intensive imaging. Vessels and devices were analyzed at early (≤98 days, n = 10) and late (180 ± 30 days, n = 14 study devices, 1 control) termination and necropsy time-points. Results. Deployment success was 100% with all devices confirmed in filtering configuration, there were no filter-related complications, and bioconversion was 100% at termination with vessels widely patent. By 98 days for all early-incorporation analysis animals, the stabilizing cylindrical part of the Sentry frame was incorporated in the vessel wall, and the filter arms were retracted. By 180 days for all late-incorporation analysis animals, the filter arms as well as frames were stably incorporated. Conclusions. Through 180 days, there were no filter-related complications, and the study devices were all bioconverted and stably incorporated, leaving all IVCs patent.