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steerable introducer
Freudenberg Medical
Summary: The steerable introducer by Freudenberg Medical is a device used primarily in embolization-coils procedures. Key evidence highlights its role in enhancing procedural success in complex cardiac interventions.
FDA Clearance Information
Pathway
510K
Number
K191190 ↗
Decision Date
August 1, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The steerable introducer was cleared by the FDA through the 510(k) pathway on August 1, 2019. It is manufactured by Freudenberg Medical and classified as a Class 2 device.
What It Is
The steerable introducer is a medical device designed to facilitate the insertion and navigation of catheters and other instruments within the vascular system. It is primarily used in interventional cardiology and radiology for procedures requiring precise catheter placement.
Clinical Applications
Common clinical scenarios for the steerable introducer include catheter ablation for atrial fibrillation, transseptal puncture, and lead extraction procedures. It provides enhanced control and precision in navigating complex vascular pathways.
Evidence Summary
The literature includes 15 studies ranging from 2022 to 2025, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies explore the device's application in cardiac interventions and its impact on procedural outcomes.
Reported Outcomes
Published studies report that the steerable introducer enhances procedural success in catheter ablation and transseptal puncture by improving catheter control and precision. It has been shown to facilitate complex procedures like mitral paravalvular leak closure and lead extraction.
Safety Profile
Reported complications include challenges in grasping leads during extraction and the technical demands of transseptal puncture. However, no significant adverse events have been consistently reported across studies.
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 explore additional clinical applications.
Frequently Asked Questions
What are the clinical indications for steerable introducer?
The steerable introducer is indicated for use in procedures requiring precise catheter placement, such as embolization-coils, catheter ablation, and transseptal puncture.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success and precision in catheter-based interventions, particularly in complex cardiac procedures.
What complications have been reported?
Safety data indicate potential challenges in lead extraction and technical demands in transseptal puncture, but no significant adverse events have been consistently reported.
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.