đź“‹ FDA Reference

wallstent tips iliac venous endoprosthesis with unistep plus delivery system

Boston Scientific

Summary: The Wallstent Tips Iliac Venous Endoprosthesis is a vascular stent system used primarily by interventional radiologists and vascular surgeons to manage venous obstructions. It is designed to support vessel patency in the iliac veins.

FDA Clearance Information

Pathway PMA
Decision Date January 17, 2003
Product Code MIR
Device Class Class 3
Evidence 5 studies

The Wallstent Tips Iliac Venous Endoprosthesis was cleared by the FDA on January 17, 2003, under PMA P930031. Manufactured by Boston Scientific, it is a Class 3 medical device.

What It Is

The Wallstent Tips Iliac Venous Endoprosthesis is a self-expanding stent system designed to maintain patency in the iliac veins. It is delivered via the Unistep Plus Delivery System, which allows for precise placement and deployment. The stent is made of a flexible, braided stainless steel mesh, providing durability and adaptability to the vessel's natural contours.

Clinical Applications

This device is commonly used in procedures to treat iliac vein compression or obstruction, often seen in conditions such as May-Thurner syndrome. It is typically utilized in interventional radiology and vascular surgery settings. Patients who benefit from this device often present with symptoms of venous insufficiency or deep vein thrombosis.

Indications for Use

The FDA indications highlight a change in the manufacturing process, specifically in the delivery system's catheter hub bond cure time. Clinically, this device is used for patients requiring venous stenting due to obstructions or compressions in the iliac veins.

Practical Considerations

The Wallstent is available in various sizes to accommodate different vessel diameters. It is compatible with standard interventional radiology equipment. Proper sizing and deployment technique are crucial for optimal outcomes and minimizing complications.

Related Literature

The linked study discusses a case where a donor iliac vein was used during liver transplantation in a patient with a migrated transjugular intrahepatic portosystemic shunt (TIPS). The study highlights the challenges of managing TIPS malposition during orthotopic liver transplantation. Although not directly related to the Wallstent, it underscores the complexity of venous interventions in the context of liver surgery.

Linked Studies (5)

PubMed • 2023

A practice audit of short-term outcomes of Wallstents versus Venovo stents for the treatment of nonthrombotic iliac vein outflow stenoses.

Journal of vascular surgery. Venous and lymphatic disorders

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

Smaller diameter sheaths are required to safely perform transradial neurointerventions.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2006

[Interventional revascularization for severe mesenteric ischemia in contribution with venal artery angioplasty].

VASA. Zeitschrift fur Gefasskrankheiten

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2002

Use of an introducer sheath for colonic stent placement.

European radiology

Other View Source →
PubMed • 2002

[Prevalence of stenosis and thrombosis of central veins in hemodialysis after a tunneled jugular catheter].

Nephrologie

View Source →

Frequently Asked Questions

What is the Wallstent Tips Iliac Venous Endoprosthesis used for?

It is used to maintain patency in the iliac veins, often in cases of venous obstruction or compression.

What specialties typically use this device?

Interventional radiologists and vascular surgeons commonly use this device.

What are the FDA-cleared indications?

The device is indicated for use in maintaining iliac vein patency, with a noted change in the delivery system's manufacturing process.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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