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amplatzer torq vue lp delivery system
St Jude Medical
Summary: The Amplatzer Torq Vue LP Delivery System is a medical device used for the delivery of venous stents. It is primarily used by interventional cardiologists and radiologists to treat venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K131063 ↗
Decision Date
August 15, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer Torq Vue LP Delivery System was cleared through the FDA 510(k) pathway on August 15, 2013. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Amplatzer Torq Vue LP Delivery System is a specialized catheter system designed to facilitate the precise placement of venous stents. It features a flexible, torqueable shaft that allows for controlled navigation through the vascular system. The system is engineered to provide stability and accuracy during stent deployment, which is critical in ensuring optimal placement and function of the stent.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings for procedures involving the treatment of venous obstructions, such as those found in patients with chronic venous insufficiency or post-thrombotic syndrome. It is particularly useful in hospital catheterization labs where precise stent placement is necessary. The device is suitable for adult patients who require venous stenting to restore proper blood flow.
Indications for Use
The FDA has cleared this device for use in the delivery of venous stents, which are used to treat conditions that cause narrowing or blockage of veins. This includes patients with conditions like deep vein thrombosis or chronic venous insufficiency.
Practical Considerations
The Amplatzer Torq Vue LP Delivery System is available in various sizes to accommodate different patient anatomies and stent sizes. It is compatible with a range of stents and requires familiarity with catheter-based techniques for optimal use. Clinicians should be trained in interventional procedures to ensure safe and effective deployment.
Frequently Asked Questions
What is the Amplatzer Torq Vue LP Delivery System used for?
It is used for the delivery and placement of venous stents in patients with venous obstructions.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the delivery of venous stents to treat conditions like venous obstructions and chronic venous insufficiency.
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.