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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 (LAAC). Key evidence suggests improved procedural outcomes compared to standard sheaths.
FDA Clearance Information
Pathway
510K
Number
K250426 ↗
Decision Date
April 25, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amulet Steerable Delivery Sheath received FDA clearance through the 510(k) pathway on April 25, 2025. It is manufactured by Abbott Medical and classified as a Class 2 device.
What It Is
The Amulet Steerable Delivery Sheath is a medical device used to deliver occlusion devices to the left atrial appendage. It is designed to improve the ease and accuracy of LAAC procedures, particularly in challenging anatomical scenarios.
Clinical Applications
This device is commonly used in procedures requiring left atrial appendage closure, especially in patients with complex cardiac anatomies or previous interventions that complicate standard access.
Evidence Summary
The literature includes five studies, comprising RCTs, case reports, and retrospective analyses, conducted between 2024 and 2025. These studies explore the device's procedural efficacy and safety profile.
Reported Outcomes
Published studies report that the Amulet Steerable Delivery Sheath enhances procedural success rates in LAAC, particularly in patients with enlarged left atria. The device is associated with improved positioning and reduced procedural time compared to standard sheaths.
Safety Profile
Reported complications include device malposition and procedural difficulties, as noted in retrospective analyses. However, comprehensive real-world safety data remain limited.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and long-term efficacy.
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 challenging cardiac anatomies.
What outcomes have been reported in clinical studies?
Studies report improved procedural success and device positioning in LAAC procedures using the Amulet Steerable Delivery Sheath.
What complications have been reported?
Safety data indicate potential complications such as device malposition and procedural challenges, though comprehensive safety data are limited.
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.