Option ELITE Retrievable Vena Cava Filter System - Vena cava filter, optional

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

Culpan Medical Pty Ltd

Classe:

Class III

Fabricado por:

Argon Medical Devices Inc 1445 Flat Creek Road, Athens, Texas, 75751 United States Of America

Área terapêutica:

44864 - Vena cava filter, optional

Indicações terapêuticas:

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 70cm filter system is suitable for jugular or femoral delivery. Indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: - Pulmonary thromboembolism when anticoagulants are contraindicated - Failure of anticoagulant therapy in thromboembolic disease - Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced - Chronic, recurrent pulmonary embolism where 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.

Status de autorização:

A

Data de autorização:

2016-12-19