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balloon expandable transseptal indroducer models beti-1840 and beti-1870
Onset Medical
Summary: The balloon expandable transseptal introducer models BETI-1840 and BETI-1870 by Onset Medical are used for transseptal access in cardiac procedures. Key evidence highlights their role in preventing coronary obstruction during redo-TAVI procedures.
FDA Clearance Information
Pathway
510K
Number
K062852 ↗
Decision Date
February 23, 2007
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on February 23, 2007. Manufactured by Onset Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The balloon expandable transseptal introducer is designed to facilitate transseptal access in cardiac procedures. It is used to introduce catheters and other devices into the left atrium via the interatrial septum.
Clinical Applications
Commonly used in procedures requiring transseptal access, such as mitral valve interventions and left atrial appendage closures. It provides a stable and reliable pathway for device delivery.
Evidence Summary
The available literature includes four studies, ranging from 2018 to 2025, covering various aspects of transcatheter procedures. Study types include RCTs and prospective analyses.
Reported Outcomes
Published studies report that the device is effective in facilitating transseptal access, with particular success in preventing coronary obstruction during redo-TAVI procedures. The device has shown utility in maintaining coronary access post-procedure.
Safety Profile
Reported complications include potential coronary obstruction and challenges in coronary access. However, the device has been associated with successful mitigation of these risks in clinical settings.
Evidence Limitations
The evidence is limited by a small number of studies, with a need for more extensive trials to confirm long-term safety and efficacy. Further research is needed to explore its use in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for balloon expandable transseptal introducer?
The device is indicated for use in procedures requiring transseptal access, such as mitral valve interventions and left atrial appendage closures.
What outcomes have been reported in clinical studies?
Studies have reported effective prevention of coronary obstruction and maintenance of coronary access during redo-TAVI procedures.
What complications have been reported?
Reported complications include potential coronary obstruction and challenges in coronary access, though these are mitigated in clinical practice.
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.