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heartspan fixed curve braided transseptal sheath
Merit Medical Systems
Summary: The HeartSpan Fixed Curve Braided Transseptal Sheath is a medical device used to facilitate transseptal access in cardiac procedures. It is primarily used by cardiologists and electrophysiologists during catheter-based interventions.
FDA Clearance Information
Pathway
510K
Number
K132720 ↗
Decision Date
February 12, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The HeartSpan Fixed Curve Braided Transseptal Sheath was cleared through the FDA 510(k) pathway on February 12, 2014. Manufactured by Merit Medical Systems, it is classified as a Class 2 device under product code DYB.
What It Is
The HeartSpan Fixed Curve Braided Transseptal Sheath is a specialized catheter sheath designed to provide stable and reliable transseptal access to the left atrium of the heart. It features a braided construction for enhanced flexibility and torque control, allowing precise navigation through the heart's anatomy. This device is essential in procedures requiring access to the left atrium, such as ablations or other electrophysiological interventions.
Clinical Applications
This device is commonly used in electrophysiology labs and cardiac catheterization suites. It is vital for procedures like atrial fibrillation ablation, where precise access to the left atrium is necessary. Cardiologists and electrophysiologists use this sheath to facilitate catheter-based interventions in adult patients, particularly those with complex cardiac arrhythmias.
Indications for Use
The HeartSpan Fixed Curve Braided Transseptal Sheath is indicated for use in patients requiring transseptal access to the left atrium, typically during procedures like catheter ablation for arrhythmias. It is suitable for patients undergoing interventions that necessitate precise and stable access to the heart's left side.
Practical Considerations
The sheath is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard transseptal needles and guidewires. Clinicians should be familiar with transseptal puncture techniques and consider patient-specific anatomical variations when selecting the appropriate sheath size.
Frequently Asked Questions
What is the HeartSpan Fixed Curve Braided Transseptal Sheath used for?
It is used to provide stable transseptal access to the left atrium during cardiac procedures such as catheter ablation for arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during catheter-based cardiac interventions.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring transseptal access to the left atrium, such as catheter ablation for cardiac arrhythmias.
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.