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aveir introducer
Abbott Medical
Summary: The Aveir Introducer by Abbott Medical is a device used for the implantation of leadless pacemakers. It is primarily used in procedures to avoid complications associated with transvenous leads. Key evidence highlights its role in improving procedural outcomes.
FDA Clearance Information
Pathway
510K
Number
K211989 ↗
Decision Date
July 27, 2021
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Aveir Introducer was cleared by the FDA via the 510(k) pathway on July 27, 2021. It is manufactured by Abbott Medical and classified as a Class 2 device under product code DYB.
What It Is
The Aveir Introducer is a medical device designed to facilitate the implantation of leadless pacemakers. It is used in clinical settings to provide a minimally invasive approach to pacemaker implantation, reducing the risk of complications associated with traditional transvenous systems.
Clinical Applications
The device is commonly used in scenarios where patients require pacemaker implantation but are at risk for complications from transvenous leads. It is particularly useful in patients with a history of lead-related issues or those who require a less invasive procedure.
Evidence Summary
The literature includes three studies, ranging from 2023 to 2025, encompassing various study types such as RCTs and retrospective analyses. These studies provide insights into procedural outcomes and safety profiles of the Aveir leadless pacemaker system.
Reported Outcomes
Published studies report that the Aveir Introducer is associated with improved procedural outcomes in the implantation of leadless pacemakers. The dual-chamber leadless pacemaker system demonstrated effective atrioventricular synchronous pacing. The helix-fixation ventricular leadless pacemaker showed potential in reducing complications compared to traditional systems.
Safety Profile
Reported complications include adverse events related to the implantation of leadless pacemakers, as identified in the FDA MAUDE database. The studies highlight the potential for reduced lead-related complications, though specific adverse events were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the relatively small number of studies and the lack of long-term follow-up data. Further research is needed to fully understand the long-term safety and efficacy of the Aveir Introducer in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Aveir Introducer?
The Aveir Introducer is indicated for use in the implantation of leadless pacemakers, particularly in patients at risk for complications from transvenous leads.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural outcomes and effective pacing with the Aveir leadless pacemaker system.
What complications have been reported?
Safety data indicate potential reductions in lead-related complications, though specific adverse events were not detailed in the provided 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.