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amplatzer torqvue low profile delivery system
Aga Medical
Summary: The Amplatzer TorqVue Low Profile Delivery System is a medical device used for the delivery of venous stents. It is primarily utilized by interventional cardiologists and radiologists in procedures involving venous access.
FDA Clearance Information
Pathway
510K
Number
K080757 ↗
Decision Date
April 18, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer TorqVue Low Profile Delivery System was cleared through the FDA 510(k) pathway on April 18, 2008. It is manufactured by Aga Medical and classified as a Class 2 device.
What It Is
The Amplatzer TorqVue Low Profile Delivery System is designed to facilitate the precise placement of venous stents. It features a low-profile design that allows for easier navigation through the vascular system, particularly in complex or tortuous anatomy. This system is essential for procedures requiring the deployment of stents in venous structures, ensuring accurate placement and stability.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures involving the placement of venous stents. It is particularly useful in treating conditions such as venous obstructions or fistulas. The system is often employed in hospital settings, catering to adult patients with complex vascular conditions.
Indications for Use
The FDA indications for this device include its use in the delivery of venous stents. It is intended for patients requiring stent placement in venous structures, particularly in cases where precise navigation and placement are critical.
Practical Considerations
The Amplatzer TorqVue Low Profile Delivery System is compatible with a range of stent sizes, making it versatile for various clinical scenarios. Clinicians should be familiar with the device's handling and deployment techniques to ensure optimal outcomes. Its low-profile design aids in navigating challenging vascular anatomy.
Related Literature
The linked study discusses the percutaneous closure of a complex coronary-to-pulmonary-artery fistula using a retrograde approach. A 60-year-old female patient with a history of coronary artery stenting and previous fistula surgery was treated. The study highlights the challenges of navigating tortuous vascular anatomy and the importance of selecting appropriate delivery systems. Limitations include the study's focus on a single case, which may not be generalizable.
Frequently Asked Questions
What is Amplatzer TorqVue Low Profile Delivery System used for?
It is used for the delivery and placement of venous stents in the vascular system.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the delivery of venous stents, particularly in complex vascular anatomy.
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.