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amplatzer steerable delivery sheath
Abbott Medical
Summary: The Amplatzer Steerable Delivery Sheath is a device designed to facilitate left atrial appendage closure, primarily used in patients with non-valvular atrial fibrillation. Key evidence highlights its utility in challenging anatomies.
FDA Clearance Information
Pathway
510K
Number
K220340 ↗
Decision Date
March 9, 2022
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer Steerable Delivery Sheath was cleared through the FDA 510(k) pathway on March 9, 2022. It is manufactured by Abbott Medical and classified as a Class 2 device.
What It Is
The Amplatzer Steerable Delivery Sheath is a medical device used to deliver occlusion devices to the left atrial appendage. It is designed to improve procedural outcomes by providing enhanced maneuverability and control during the procedure.
Clinical Applications
This device is commonly used in procedures involving left atrial appendage closure, particularly in patients with non-valvular atrial fibrillation who are at risk of stroke and cannot tolerate long-term anticoagulation therapy.
Evidence Summary
The available literature includes six studies, comprising randomized controlled trials and case series, published between 2021 and 2025. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Amplatzer Steerable Delivery Sheath improves procedural success rates in left atrial appendage closure, especially in anatomically challenging cases. The device has shown to facilitate better positioning and deployment of occlusion devices, potentially reducing procedural time and improving patient outcomes.
Safety Profile
Reported complications include device-related adverse events, though specific details are limited in the available literature. One study highlights real-world adverse events associated with the device, emphasizing the need for careful patient selection and procedural planning.
Evidence Limitations
The 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 device's safety profile and its performance 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 at risk of stroke and cannot tolerate long-term anticoagulation.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates and better device positioning in left atrial appendage closure, especially in challenging anatomical cases.
What complications have been reported?
Reported complications include device-related adverse events, though specific details are limited in the available literature.
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.