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…
- GMDN category: Vena cava filter, optional
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.