đź“‹ FDA Reference
amplatzer torqvue exchange system
Aga Medical
Summary: The Amplatzer TorqVue Exchange System is a medical device used in venous stenting procedures. It is primarily utilized by interventional cardiologists and vascular specialists.
FDA Clearance Information
Pathway
510K
Number
K080994 ↗
Decision Date
May 16, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer TorqVue Exchange System was cleared through the FDA 510(k) pathway on May 16, 2008. Manufactured by Aga Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Amplatzer TorqVue Exchange System is a delivery system designed to facilitate the placement of stents within the venous system. It provides a controlled and precise method for delivering stents to targeted areas, ensuring optimal positioning and deployment. The system is engineered to navigate complex venous anatomy, making it a valuable tool in interventional procedures.
Clinical Applications
This device is commonly used in procedures involving venous stenting, particularly in cases of venous obstruction or insufficiency. It is frequently employed in interventional cardiology and vascular surgery settings, where precision and control are paramount. Patients with conditions such as deep vein thrombosis or chronic venous insufficiency may benefit from procedures utilizing this system.
Indications for Use
The FDA indications for the Amplatzer TorqVue Exchange System include its use in the placement of venous stents. It is intended for patients who require stenting to address venous blockages or insufficiencies, improving blood flow and reducing symptoms associated with these conditions.
Practical Considerations
Clinicians should be aware of the typical sizing options available for the Amplatzer TorqVue Exchange System to ensure compatibility with various stent sizes. Proper technique is essential to navigate the venous anatomy effectively, and familiarity with the device's handling characteristics can enhance procedural success.
Frequently Asked Questions
What is the Amplatzer TorqVue Exchange System used for?
It is used for the delivery and placement of venous stents in patients with venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional cardiologists and vascular specialists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in the placement of venous stents to treat blockages or insufficiencies in the venous system.
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.