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Duo Venous Stent System

FDA PMA

Class III (US FDA PMA)

PMA P230021

by Philips Image Guided Therapy Corporation

Identity

Trade Name
Duo Venous Stent System FDA PMA
Generic Name
Stent, iliac vein FDA PMA

Identifiers

PMA Number
P230021 FDA PMA
FDA Product Code
QAN FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The Duo Venous Stent System is a Class III self-expanding stent designed for placement in the iliofemoral veins. It is intended to treat symptomatic venous outflow obstruction, with specific variants—Duo Hybrid and Duo Extend—tailored for iliac and common iliac/femoral vein applications, respectively. The Duo Hybrid is restricted to use at the confluence of the inferior vena cava, while the Duo Extend extends coverage into smaller-diameter caudal veins.

This system is supplied as a sterile, single-use device and is regulated under an FDA Premarket Approval (PMA). The Duo Venous Stent System is delivered via catheter-based deployment, requiring fluoroscopic guidance for precise placement. Each variant (Hybrid and Extend) is engineered for overlapping use to minimize risks such as stent fracture or corrosion, with sizes and configurations determined by anatomical requirements. Authorized under PMA number P230021, it adheres to FDA Class III regulatory standards for venous stents.

Frequently asked questions

What specific veins is the Duo Venous Stent System designed to treat, and how do the Duo Hybrid and Duo Extend variants differ in their applications?

The Duo Venous Stent System is designed to treat symptomatic venous outflow obstruction in the iliofemoral veins. The Duo Hybrid variant is specifically intended for placement in the iliac vein at the confluence with the inferior vena cava, while the Duo Extend variant is designed to cover the common iliac and common femoral veins, extending coverage into smaller-diameter caudal veins. This modular design allows for overlapping use to reduce risks like stent fracture or corrosion, ensuring better anatomical fit.

Is the Duo Venous Stent System intended for reuse, and how should it be stored if sterile?

The Duo Venous Stent System is supplied as a sterile, single-use device, meaning it is not intended for reuse. Since it is sterile upon packaging, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures to maintain sterility and functionality until use.

What deployment method is required for the Duo Venous Stent System, and why is this important?

The Duo Venous Stent System is deployed via a catheter-based approach under fluoroscopic guidance to ensure precise placement within the iliofemoral veins. Fluoroscopy provides real-time imaging, which is critical for accurate stent positioning, minimizing risks of misplacement or complications during the procedure.

How does the Duo Venous Stent System’s regulatory approval process differ from other venous stents, and what does this mean for clinicians?

The Duo Venous Stent System is regulated under an FDA Premarket Approval (PMA) process, which is required for Class III devices like venous stents due to their higher risk profile. This means the system underwent rigorous clinical trials and review to demonstrate safety and effectiveness before approval. For clinicians, this indicates the device has met stringent regulatory standards, but it also means they should follow the approved indications and deployment guidelines precisely.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Duo Venous Stent System - Philips - Philips, Duo Venous Stent System | Philips, Deep Venous Procedures & Solutions - Philips

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Philips Image Guided Therapy Corporation

Sources (1)

  • FDA PMA P230021 24 fields · synced Oct 6, 2026