Duo Venous Stent System - Duo Hybrid and Duo Extend

Engineered for greater crush resistance and flexibility, Duo Venous Stent System is built to address the multiple anatomical challenges of the deep venous system and includes two stents – Duo Hybrid and Duo Extend. [1] This distinctive portfolio of self-expending venous stents offers the ability to treat a broad range of patients with chronic venous insufficiency (CVI) – from simple to complex lesions. Duo Hybrid is designed to work independently or in conjunction with Duo Extend to provide clinical versatility.

Important safety information for Philips Duo Venous Stent System

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Duo Hybrid

Duo Hybrid features a distinct design that uniquely combines varied stent properties into a single stent without compromise. It seamlessly integrates precise mechanical properties along the stent length for targeted crush resistance, flexibility and durability. [1]

Duo Extend

When additional coverage is needed, Duo Extend stent smoothly overlaps with Duo Hybrid to extend therapy. [1] These two stents are designed to work together while providing an option to stent into the caudal vein with a smaller diameter. [2] Duo Extend is to be used only in combination with Duo Hybrid and is not indicated for independent use.

Product specifications

Duo Hybrid	Duo Extend
12 diam \| 60 mm length \| 9F	12 diam \| 40 mm length \| 9F
12 diam \| 80 mm length \| 9F	12 diam \| 60 mm length \| 9F
12 diam \| 100 mm length \| 9F	12 diam \| 80 mm length \| 9F
12 diam \| 120 mm length \| 9F	12 diam \| 100 mm length \| 9F
12 diam \| 140 mm length \| 9F	12 diam \| 120 mm length \| 9F
12 diam \| 160 mm length \| 9F	12 diam \| 140 mm length \| 9F
14 diam \| 60 mm length \| 9F	14 diam \| 40 mm length \| 9F
14 diam \| 80 mm length \| 9F	14 diam \| 60 mm length \| 9F
14 diam \| 100 mm length \| 9F	14 diam \| 80 mm length \| 9F
14 diam \| 120 mm length \| 9F	14 diam \| 100 mm length \| 9F
14 diam \| 140 mm length \| 9F	14 diam \| 120 mm length \| 9F
14 diam \| 160 mm length \| 9F	14 diam \| 140 mm length \| 9F
16 diam \| 60 mm length \| 10F	16 diam \| 40 mm length \| 10F
16 diam \| 80 mm length \| 10F	16 diam \| 60 mm length \| 10F
16 diam \| 100 mm length \| 10F	16 diam \| 80 mm length \| 10F
16 diam \| 120 mm length \| 10F	16 diam \| 100 mm length \| 10F
16 diam \| 140 mm length \| 10F	16 diam \| 120 mm length \| 10F
16 diam \| 160 mm length \| 10F	16 diam \| 140 mm length \| 10F
18 diam \| 60 mm length \| 10F
18 diam \| 80 mm length \| 10F
18 diam \| 100 mm length \| 10F
18 diam \| 120 mm length \| 10F
18 diam \| 140 mm length \| 10F
18 diam \| 160 mm length \| 10F

VIVID clinical trial summary

Clinical data summary for VIVID trial using Philips Duo Venous Stent System

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Disclaimer

[1] Data on file: REF-00043, REF-00046, REF-00048

[2] Data on file: REF-00044, REF-00045, REF-00047

Caution: Federal law restricts this device to sale by or on the order of a physician.

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.

Duo Hybrid	Duo Extend
12 diam \| 60 mm length \| 9F	12 diam \| 40 mm length \| 9F
12 diam \| 80 mm length \| 9F	12 diam \| 60 mm length \| 9F
12 diam \| 100 mm length \| 9F	12 diam \| 80 mm length \| 9F
12 diam \| 120 mm length \| 9F	12 diam \| 100 mm length \| 9F
12 diam \| 140 mm length \| 9F	12 diam \| 120 mm length \| 9F
12 diam \| 160 mm length \| 9F	12 diam \| 140 mm length \| 9F
14 diam \| 60 mm length \| 9F	14 diam \| 40 mm length \| 9F
14 diam \| 80 mm length \| 9F	14 diam \| 60 mm length \| 9F
14 diam \| 100 mm length \| 9F	14 diam \| 80 mm length \| 9F
14 diam \| 120 mm length \| 9F	14 diam \| 100 mm length \| 9F
14 diam \| 140 mm length \| 9F	14 diam \| 120 mm length \| 9F
14 diam \| 160 mm length \| 9F	14 diam \| 140 mm length \| 9F
16 diam \| 60 mm length \| 10F	16 diam \| 40 mm length \| 10F
16 diam \| 80 mm length \| 10F	16 diam \| 60 mm length \| 10F
16 diam \| 100 mm length \| 10F	16 diam \| 80 mm length \| 10F
16 diam \| 120 mm length \| 10F	16 diam \| 100 mm length \| 10F
16 diam \| 140 mm length \| 10F	16 diam \| 120 mm length \| 10F
16 diam \| 160 mm length \| 10F	16 diam \| 140 mm length \| 10F
18 diam \| 60 mm length \| 10F
18 diam \| 80 mm length \| 10F
18 diam \| 100 mm length \| 10F
18 diam \| 120 mm length \| 10F
18 diam \| 140 mm length \| 10F
18 diam \| 160 mm length \| 10F