Sentry Bioconvertible Inferior Vena Cava Filter: Study of Stages of Incorporation in an Experimental Ovine Model.

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. To evaluate the performance and stages of incorporation of the Sentry IVC filter in an ovine model. 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.

EU and US clinical investigation adverse event reporting.

Revised international standards on clinical investigations were recently published. ISO 14155 consists of two parts under the general title Clinical Investigation of Medical Devices for Human Subjects. This article outlines the requirements of the revised standard and contrasts these with United States reporting requirements.