Device Dossier

OptEase Retrievable Vena Cava Filter - Vena cava filter, optional

Device Dossier for OptEase Retrievable Vena Cava Filter - Vena cava filter, optional (Vena cava filter, optional, Class III, sponsor Cordis). ARTG…

Intended purpose

The OPTEASE Retrievable Filter is indicated for the prevention of pulmonary embolism (PE) via percutaneous placement in the IVC in patients considered at high risk of PE.

Functional description

The Optease Filter’s Introduction kit consist of a filter storage tube, a 6F Brite Tip catheter sheath introducer, an Angiographic Vessel Dilator and obturator. The obturator advances the filter from its tube into the introducer to the implantation site. The dilator is used with the sheath introducer as a dilator and to provide angiographic visualization. The filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability.

TGA Public Summary