đź“Š Evidence-Based Reference
amulet steerable delivery sheath
Abbott Medical
Summary: The Amulet Steerable Delivery Sheath by Abbott Medical is a device designed to facilitate left atrial appendage closure. It is FDA 510k cleared and supported by five studies highlighting its procedural efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K232690 ↗
Decision Date
September 29, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amulet Steerable Delivery Sheath was cleared through the FDA 510k pathway on September 29, 2023. Manufactured by Abbott Medical, it is classified as a Class 2 device.
What It Is
The Amulet Steerable Delivery Sheath is a medical device used to aid in the delivery of closure devices for the left atrial appendage. It is designed to improve procedural outcomes by providing enhanced maneuverability and control during the intervention.
Clinical Applications
This device is commonly used in procedures involving left atrial appendage closure, particularly in patients with atrial fibrillation to prevent thromboembolic events. It is especially useful in challenging anatomical scenarios, such as enlarged left atria.
Evidence Summary
The literature includes five studies, comprising randomized controlled trials, case reports, and retrospective analyses, conducted between 2024 and 2025. These studies explore the procedural efficacy and safety of the device.
Reported Outcomes
Published studies report that the Amulet Steerable Delivery Sheath improves procedural success rates in left atrial appendage closure. It is noted for its ability to facilitate device positioning, particularly in patients with complex cardiac anatomy.
Safety Profile
Reported complications include device malposition and procedural difficulties, as highlighted in the MAUDE database study. However, overall safety profiles are comparable to standard delivery systems.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and to evaluate outcomes in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Amulet Steerable Delivery Sheath?
The device is indicated for use in left atrial appendage closure procedures, particularly in patients with atrial fibrillation to reduce the risk of stroke.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success rates and effective device positioning, especially in patients with challenging cardiac anatomy.
What complications have been reported?
Safety data indicate complications such as device malposition and procedural difficulties, though these are consistent with other delivery systems.
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.