đź“Š Evidence-Based Reference
amplatzer torqvue 3 delivery sheath model 9-tv3-08f104 9-tv3-08f54
Aga Medical
Summary: The Amplatzer TorqVue 3 Delivery Sheath is a medical device used primarily for venous stent delivery. Cleared by the FDA via the 510k pathway, it is supported by two studies focusing on its application in cardiac procedures.
FDA Clearance Information
Pathway
510K
Number
K091793 ↗
Decision Date
July 9, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer TorqVue 3 Delivery Sheath, manufactured by Aga Medical, received FDA clearance through the 510k pathway on July 9, 2009. It is classified as a Class 2 device under product code DQY.
What It Is
The Amplatzer TorqVue 3 Delivery Sheath is designed for the delivery of venous stents, particularly in cardiac procedures. It facilitates the placement of devices within the vascular system, aiding in the treatment of conditions such as atrial fibrillation.
Clinical Applications
This device is commonly used in procedures requiring the delivery of stents to the venous system, such as left atrial appendage closure in patients with atrial fibrillation. It provides a conduit for precise device placement.
Evidence Summary
The available literature includes two studies: one published in 2015 and another with an unknown date. These studies explore the device's application in cardiac procedures, including observational and prospective research designs.
Reported Outcomes
Published studies report that the Amplatzer TorqVue 3 Delivery Sheath is effective in facilitating left atrial appendage closure. The device has been shown to support successful stent placement in cardiac procedures, contributing to improved patient outcomes.
Safety Profile
Reported complications include typical procedural risks associated with venous stent delivery, such as vascular injury or device malposition. However, specific safety data from the provided studies is limited.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of comprehensive safety data. Further research is needed to fully understand the long-term outcomes and potential complications associated with the device.
Frequently Asked Questions
What are the clinical indications for Amplatzer TorqVue 3 Delivery Sheath?
The device is indicated for the delivery of venous stents, particularly in procedures like left atrial appendage closure in patients with atrial fibrillation.
What outcomes have been reported in clinical studies?
Studies have reported successful stent placement and effective facilitation of left atrial appendage closure, contributing to improved procedural outcomes.
What complications have been reported?
Reported complications include procedural risks such as vascular injury or device malposition, though specific safety data is limited.
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.