Option Elite 100cm Retievable Vena Cava Filter System - Vena cava filter, optional
Access comprehensive regulatory information for Option Elite 100cm Retievable Vena Cava Filter System - Vena cava filter, optional in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Culpan Medical Pty Ltd, manufactured by Argon Medical Devices Inc in United States of America. The device registration started on January 17, 2017.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
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.