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amplatzer torqvue delivery system
Aga Medical
Summary: The Amplatzer TorqVue Delivery System is a medical device used for the delivery of occlusion devices in venous stenting procedures. Key evidence includes its application in complex coronary-to-pulmonary-artery fistula cases.
FDA Clearance Information
Pathway
510K
Number
K072313 ↗
Decision Date
November 2, 2007
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer TorqVue Delivery System was cleared by the FDA via the 510(k) pathway on November 2, 2007. It is manufactured by Aga Medical and classified as a Class 2 device.
What It Is
The Amplatzer TorqVue Delivery System is designed to facilitate the delivery of occlusion devices within the vascular system, particularly in venous stenting procedures. It is intended for use by clinicians in interventional cardiology settings.
Clinical Applications
This device is commonly used in procedures requiring the precise placement of occlusion devices, such as in the treatment of coronary-to-pulmonary-artery fistulas and other vascular anomalies.
Evidence Summary
The available literature includes four studies, comprising case series and observational studies, with publication years ranging from 2016 to 2022. These studies explore the device's application in various clinical scenarios.
Reported Outcomes
Published studies report successful outcomes in the closure of complex coronary-to-pulmonary-artery fistulas and effective left atrial appendage closure using the device. The evidence suggests feasibility and effectiveness in these applications.
Safety Profile
Reported complications include procedural challenges related to device placement, but specific adverse events are not detailed in the provided studies. Overall, the device is considered safe when used as intended.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Amplatzer TorqVue Delivery System?
The device is indicated for use in venous stenting procedures, particularly in the delivery of occlusion devices for vascular anomalies such as coronary-to-pulmonary-artery fistulas.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful closure of complex vascular anomalies and effective device placement in targeted procedures.
What complications have been reported?
Safety data from the evidence indicates procedural challenges, but specific adverse events are not extensively detailed.
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.