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tsp crosser transseptal access system
Transseptal Solutions
Summary: The TSP Crosser Transseptal Access System is a medical device used for transseptal access and catheter navigation in the left atrium, primarily utilized by cardiologists during procedures such as left atrial ablations.
FDA Clearance Information
Pathway
510K
Number
K181088 ↗
Decision Date
September 28, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The TSP Crosser Transseptal Access System was cleared through the FDA 510(k) pathway on September 28, 2018. It is manufactured by Transseptal Solutions and classified as a Class 2 device under product code DYB.
What It Is
The TSP Crosser Transseptal Access System is designed to facilitate transseptal access to the left atrium, a critical step in various cardiac procedures. It allows clinicians to safely and effectively navigate catheters across the atrial septum, minimizing the risk of complications. This system is particularly useful in procedures requiring precise catheter placement, such as atrial fibrillation ablations.
Clinical Applications
This device is commonly used in electrophysiology labs and cardiac catheterization settings. It is essential for cardiologists performing procedures that require access to the left atrium, such as pulmonary vein isolation or mitral valve interventions. The system is beneficial for adult patients undergoing complex cardiac procedures where transseptal access is necessary.
Indications for Use
The TSP Crosser is indicated for use in patients requiring transseptal access to the left atrium, typically during cardiac procedures like ablations or valve repairs. It is designed to enhance the safety and efficacy of these interventions.
Practical Considerations
Clinicians should be aware of the compatibility of the TSP Crosser with existing catheter systems. Proper sizing and technique are crucial for optimal performance, and training in transseptal puncture techniques is recommended for users.
Related Literature
The linked study focused on evaluating the TSP Crosser System's effectiveness in achieving transseptal access and facilitating left atrial catheter navigation. While specific results are not detailed, the study likely assessed procedural success rates and safety outcomes. Limitations may include a lack of long-term follow-up data and a small sample size.
Frequently Asked Questions
What is the TSP Crosser Transseptal Access System used for?
It is used for transseptal access to the left atrium during cardiac procedures such as ablations.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and interventional cardiology, use this device.
What are the FDA-cleared indications?
The device is indicated for transseptal access to the left atrium in cardiac procedures.
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.