📊 Evidence-Based Reference
amplatzer torqvue 45degreex45degree delivery sheath models 9-tv45x45-09f-100 9-tv45x45-10f-100
Aga Medical
Summary: The Amplatzer TorqVue 45°x45° delivery sheath is used in venous stent procedures. It is FDA-cleared and supported by studies focusing on left atrial appendage closure. Key findings highlight its feasibility and safety.
FDA Clearance Information
Pathway
510K
Number
K083214 ↗
Decision Date
May 12, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer TorqVue 45°x45° delivery sheath was cleared by the FDA via the 510(k) pathway on May 12, 2009. Manufactured by Aga Medical, it is classified as a Class 2 device.
What It Is
The Amplatzer TorqVue 45°x45° delivery sheath is a medical device designed to facilitate the delivery of venous stents. It is specifically shaped to assist in procedures such as left atrial appendage closure, providing precise control and access.
Clinical Applications
Commonly used in interventional cardiology, this device is employed in procedures requiring precise catheter navigation, such as left atrial appendage closure and patent ductus arteriosus closure in complex anatomical scenarios.
Evidence Summary
The available literature includes three studies published between 2014 and 2016. These studies encompass various methodologies, including case series and prospective analyses, focusing on the device's application in atrial appendage and ductus arteriosus closures.
Reported Outcomes
Published studies report that the Amplatzer TorqVue 45°x45° delivery sheath is effective in facilitating left atrial appendage closure. The 'shape-the-sheath' method has been shown to enhance procedural success, indicating its utility in complex cardiac interventions.
Safety Profile
Reported complications include technical challenges associated with anatomical variations, such as interrupted inferior caval vein. However, the studies highlight the device's overall safety and feasibility in achieving successful outcomes.
Evidence Limitations
The evidence is limited by small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and to explore its use in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Amplatzer TorqVue 45°x45° delivery sheath?
The device is indicated for use in venous stent procedures, particularly in left atrial appendage closure and patent ductus arteriosus closure.
What outcomes have been reported in clinical studies?
Studies report successful facilitation of left atrial appendage closure with enhanced procedural success using the 'shape-the-sheath' method.
What complications have been reported?
Reported complications include challenges with anatomical variations, but overall safety and feasibility are supported by the studies.
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.