Device Dossier
Option Elite 100cm Retievable Vena Cava Filter System - Vena cava filter, optional
Device Dossier for Option Elite 100cm Retievable Vena Cava Filter System - Vena cava filter, optional (Vena cava filter, optional, Class III, sponsor…
- GMDN category: Vena cava filter, optional
Intended purpose
The Option™ ELITE Vena Cava Filter 100cm System is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions: - Pulmonary thromboembolism when anticoagulant therapy is contraindicated, - Failure of anticoagulant therapy in thromboembolic diseases, - Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced, - Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated. The Filter may be removed according to supplied instructions in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.
Functional description
The filter is self centreing and has memory shaped nitinol struts designed for clot capture. Retention anchors (hooks) are located in caudal portion for fixation to vessel wall. It is flexible and expands to internal diameter of IVC and imparts outward radial force for positioning and stability. The 100cm filter system is suitable for antecubital and popliteal delivery.