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Amplatzer Torqvue Fx
Summary: The Amplatzer TorqVue FX is a medical device used for the placement of venous stents. It is typically utilized by interventional cardiologists and radiologists in procedures involving venous access.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K121611 ↗
Decision Date ?
August 23, 2012
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Amplatzer TorqVue FX was cleared through the FDA 510(k) pathway on August 23, 2012. Manufactured by Aga Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Amplatzer TorqVue FX is a delivery system designed to facilitate the placement of stents within the venous system. It consists of a catheter and a delivery sheath that allows for precise positioning and deployment of stents. This device is crucial in procedures where maintaining venous patency is necessary, such as in cases of venous obstruction.
FDA-Cleared Indications
- Delivery and deployment of compatible vascular stents in the venous system.
- Use during percutaneous procedures requiring controlled positioning of a venous stent.
Clinical Applications
- Percutaneous delivery of stents for venous stenosis or occlusion.
- Image-guided venous stenting in the iliac or central venous system when a compatible stent is selected.
- Placement of a venous stent through vascular access under fluoroscopic or other appropriate imaging guidance.
Practical Considerations
- The delivery system must be matched to the specific stent type, diameter, length and delivery requirements.
- The operator should select catheter and sheath dimensions appropriate for the patient's venous anatomy and the planned access route.
- Use requires wire access, imaging guidance and familiarity with venous stent deployment and repositioning limits.
- Contraindications and precautions include inability to obtain suitable vascular access, severe vessel tortuosity or stenosis that prevents device passage, and known incompatibility with the selected stent or accessories.
- MRI safety depends on the implanted stent and any other retained components, not only on the delivery catheter, which is removed after deployment. Consult the current device labeling for exact MRI conditions.
Procedures that use this device
Frequently Asked Questions
What is Amplatzer TorqVue FX used for?
The Amplatzer TorqVue FX is used for the delivery and placement of venous stents to maintain open venous pathways.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in procedures involving venous access and stenting.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting, particularly in patients with venous blockages or narrowing.
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.