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amplatzer steerable delivery sheath
Abbott Medical
Summary: The Amplatzer Steerable Delivery Sheath by Abbott Medical is a device designed for improved delivery in left atrial appendage closure procedures. Key evidence highlights its utility in challenging anatomies and procedural success.
FDA Clearance Information
Pathway
510K
Number
K212026 ↗
Decision Date
September 27, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer Steerable Delivery Sheath was cleared through the FDA 510(k) pathway on September 27, 2021. It is manufactured by Abbott Medical and classified as a Class 2 device under product code DQY.
What It Is
The Amplatzer Steerable Delivery Sheath is a medical device used to facilitate the delivery of occlusion devices in left atrial appendage closure procedures. It is designed to enhance maneuverability and precision in challenging anatomical scenarios.
Clinical Applications
This device is commonly used in procedures for left atrial appendage occlusion, particularly in patients with non-valvular atrial fibrillation who are at risk of thromboembolic events and are not suitable for long-term anticoagulation therapy.
Evidence Summary
The literature includes six studies ranging from 2021 to 2025, encompassing various study designs such as randomized controlled trials and case series. These studies explore the procedural outcomes and safety of the Amplatzer Steerable Delivery Sheath.
Reported Outcomes
Published studies report that the Amplatzer Steerable Delivery Sheath improves procedural outcomes in left atrial appendage closure, particularly in cases with complex anatomies. The device has been associated with a high success rate in achieving optimal occlusion and reducing procedural complications.
Safety Profile
Reported complications include device-related adverse events, although specific details are limited in the available literature. One study highlights real-world adverse events associated with the device, underscoring the need for further safety evaluations.
Evidence Limitations
The current evidence is limited by the small number of studies and the lack of long-term follow-up data. Further research is needed to fully understand the safety profile and long-term efficacy of the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Amplatzer Steerable Delivery Sheath?
The device is indicated for use in left atrial appendage closure procedures, particularly in patients with non-valvular atrial fibrillation who are not candidates for long-term anticoagulation.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates and effective occlusion in complex anatomies using the Amplatzer Steerable Delivery Sheath.
What complications have been reported?
Safety data indicate potential device-related adverse events, though specific complications are not extensively detailed in the available 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.