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modification to transseptal introducer set
Thomas Medical Products
Summary: The transseptal introducer set by Thomas Medical is a Class 2 medical device used for gaining access to the left atrium of the heart. It is primarily used by interventional cardiologists during procedures such as mitral valve repair or replacement.
FDA Clearance Information
Pathway
510K
Number
K020090 ↗
Decision Date
February 11, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The transseptal introducer set by Thomas Medical was cleared via the FDA 510k pathway on February 11, 2002. It is classified as a Class 2 device under product code DYB.
What It Is
This device is a modification to a transseptal introducer set, which is used to facilitate access to the left atrium of the heart through the interatrial septum. It consists of a sheath and dilator system that allows for safe passage of catheters and other devices into the left atrium. This is crucial for procedures that require precise intervention within the heart, such as valve repair or electrophysiological studies.
Clinical Applications
The transseptal introducer set is commonly used in interventional cardiology and electrophysiology. It is essential in procedures like mitral valve repair, atrial fibrillation ablation, and left atrial appendage closure. These procedures are typically performed in a catheterization lab or hybrid operating room, and the device is used by cardiologists and electrophysiologists treating patients with structural heart disease or arrhythmias.
Indications for Use
The FDA indications for this device involve its use in procedures that require access to the left atrium. This includes patients undergoing interventions for conditions such as mitral valve regurgitation or atrial fibrillation, where precise catheter placement is necessary.
Practical Considerations
Clinicians should be aware of the typical sizes available for the introducer set to ensure compatibility with the catheters and devices intended for use. Proper technique in transseptal puncture is crucial to avoid complications, and familiarity with the device's handling characteristics can improve procedural success.
Related Literature
The linked study investigated the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in patients with moderate-severe or severe degenerative mitral regurgitation. Although specific year and abstract details are unavailable, such studies typically assess outcomes like valve function improvement and procedural safety. Limitations might include small sample sizes or short follow-up periods, which are common in early device evaluations.
Frequently Asked Questions
What is the transseptal introducer set used for?
It is used to gain access to the left atrium of the heart for procedures such as mitral valve repair or atrial fibrillation ablation.
What specialties typically use this device?
Interventional cardiologists and electrophysiologists commonly use this device in catheterization labs or hybrid operating rooms.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring access to the left atrium, such as mitral valve interventions and atrial fibrillation treatments.
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.