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wallstent venous endoprosthesis with unistep plus delivery system
Boston Scientific
Summary: The Wallstent Venous Endoprosthesis is a stent used to treat venous obstructions. It is typically used by vascular surgeons or interventional radiologists to restore blood flow in veins.
FDA Clearance Information
Pathway PMA
Number P980033 ↗
Decision Date July 18, 2013
Product Code QKJ
Device Class Class 3
Evidence 5 studies
The Wallstent Venous Endoprosthesis was cleared by the FDA via the PMA pathway on July 18, 2013. It is manufactured by Boston Scientific and is classified as a Class 3 medical device.
What It Is
The Wallstent Venous Endoprosthesis is a self-expanding stent designed to treat venous obstructions. It is delivered using the Unistep Plus Delivery System, which allows for precise placement within the vein. The stent is made of a flexible mesh that expands to fit the vessel, providing structural support and maintaining patency.
Clinical Applications
This device is commonly used in procedures to address chronic venous insufficiency or post-thrombotic syndrome. It is typically utilized in hospital settings by vascular surgeons or interventional radiologists. The patient population includes those with venous obstructions that impede blood flow, often leading to symptoms like swelling or pain.
Indications for Use
The FDA indications suggest this device is used to support the manufacturing process of venous stents. Clinically, it is used for patients with venous blockages to restore proper blood flow.
Practical Considerations
The Wallstent comes in various sizes to accommodate different vein diameters. It is compatible with standard delivery systems and requires careful imaging guidance for accurate placement. Clinicians should be familiar with the deployment technique to ensure optimal outcomes.
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 Venous Endoprosthesis used for?
It is used to treat venous obstructions by providing structural support to maintain blood flow in veins.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in the treatment of venous obstructions to restore blood flow.
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.