1. Data on file: D062749
2. P230021 Summary of Safety and Effectiveness Document
Brief statement
Philips Duo Venous Stent System
Intended use:
The Duo Venous Stent System is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. The Duo Hybrid Stent is intended to be used in the iliac vein at the confluence of the inferior vena cava only. The Duo Extend Stent is intended for use in the common iliac and common femoral vein.
Contraindications for use:
The Duo Venous Stent System is contraindicated for the following: 1. Patients with a known hypersensitivity to nickel-titanium alloy (Nitinol). 2. Patients unable to receive standard medication used for interventional procedures including anticoagulants, contrast agents and antiplatelet therapy. 3. Patients who are judged to have a lesion that prevents complete inflation of a balloon dilation catheter or proper placement of the stent or the stent delivery system. 4. Tortuous vascular anatomy significant enough to prevent safe introduction and passage of the device to its intended location. 5. Duo Hybrid jugular or contralateral vascular access
Prior to implanting the Duo Venous Stent System, please review the instructions for use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Caution:
Federal law restricts this device to sale by or on the order of a physician.