📊 Evidence-Based Reference
Amplatzer Trevisio Intravascular Delivery System
Abbott Medical
Summary: The Amplatzer Trevisio Intravascular Delivery System is designed for precise delivery of Amplatzer devices, primarily used in atrial septal defect closures. Key evidence highlights its safety and efficacy in pediatric cases.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K190581 ↗
Decision Date ?
April 5, 2019
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Amplatzer Trevisio Intravascular Delivery System was cleared by the FDA via the 510(k) pathway on April 5, 2019. It is manufactured by Abbott Medical and classified as a Class 2 device.
What It Is
The Amplatzer Trevisio Intravascular Delivery System is a medical device used to facilitate the accurate implantation of Amplatzer devices, particularly in procedures such as atrial septal defect closures. It is intended for use in intravascular delivery applications.
FDA-Cleared Indications
- Used to facilitate the intravascular delivery and placement of compatible Amplatzer devices.
- Indications depend on the specific Amplatzer occluder or implant used with the delivery system.
- The system is cleared as a percutaneous catheter device under FDA product code DQY.
Clinical Applications
- Transcatheter delivery of compatible Amplatzer devices for atrial septal defect closure.
- Percutaneous structural-heart procedures in which an approved Amplatzer occlusion device must be advanced, positioned, and deployed.
- Delivery of compatible devices through vascular access under fluoroscopic and echocardiographic imaging, as specified in the implant's instructions for use.
Evidence Summary
The available literature includes a case series study and a post-approval study. The case series involved 9 pediatric patients and was published in 2021. The post-approval study is registered but lacks published results.
Reported Outcomes
Published studies report that the Amplatzer Trevisio system achieved successful implantation in all cases, with no device embolization or serious complications. Complete shunt closure was confirmed on follow-up, demonstrating the system's efficacy in achieving desired clinical outcomes.
Safety Profile
Reported complications include no device embolization or serious complications following closure. The shape, position, and orientation of the Amplatzer Septal Occluder were consistent before and after release, indicating a favorable safety profile.
Evidence Limitations
The evidence is limited to a small case series and an ongoing post-approval study with no published results. Further research is needed to validate findings in larger, more diverse populations and to explore long-term outcomes.
Practical Considerations
- The delivery system must be matched to the specific Amplatzer device, device size, access route, and instructions for use.
- The operator advances the system through vascular access under imaging guidance; careful flushing and preparation are required to reduce the risk of air or thrombus entering the circulation.
- Access-site bleeding, vascular injury, arrhythmia, embolization, device malposition, and other procedure-related complications are possible.
- MRI conditions and safety depend on the implanted Amplatzer device and the complete device system; the applicable implant labeling should be checked before MRI.
- Contraindications, catheter dimensions, compatible guidewires or sheaths, and size ranges are specified in the current product labeling and should not be inferred from the FDA product code alone.
Frequently Asked Questions
What are the clinical indications for Amplatzer Trevisio Intravascular Delivery System?
The device is indicated for use in intravascular delivery applications, particularly in transcatheter atrial septal defect closures.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful implantation and complete shunt closure with no serious complications.
What complications have been reported?
Safety data indicate no device embolization or serious complications in the reported cases.
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.