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heartspan steerable sheath introducer
Merit Medical Systems
Summary: The HeartSpan Steerable Sheath Introducer is a medical device used primarily in cardiac electrophysiological procedures to facilitate catheter access. It is utilized by interventional cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K170668 ↗
Decision Date
April 5, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The HeartSpan Steerable Sheath Introducer was cleared via the FDA 510(k) pathway on April 5, 2017. It is manufactured by Merit Medical Systems and classified as a Class 2 device under product code DYB.
What It Is
The HeartSpan Steerable Sheath Introducer is a specialized catheter sheath designed to provide enhanced control and maneuverability during cardiac procedures. Its steerable nature allows clinicians to navigate complex vascular pathways with precision, making it particularly useful in accessing hard-to-reach areas of the heart. The device is typically used in conjunction with other catheters and tools during electrophysiological studies and ablations.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures such as catheter ablation for arrhythmias, where precise navigation within the heart is critical. It is also employed in interventional cardiology settings for procedures requiring access to specific cardiac structures. The HeartSpan is suitable for adult patients undergoing complex cardiac interventions, particularly those involving challenging vascular anatomy.
Indications for Use
The FDA indications for the HeartSpan Steerable Sheath Introducer include facilitating catheter access during cardiac electrophysiological procedures. It is intended for use in patients requiring precise catheter placement within the heart, such as those undergoing ablation therapy for arrhythmias.
Practical Considerations
The HeartSpan Steerable Sheath Introducer comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and is designed for single-use to ensure sterility. Clinicians should be trained in its use to maximize the benefits of its steerable capabilities.
Related Literature
The linked study explored the use of steerable sheaths, like the HeartSpan, in complex aortic procedures, demonstrating their utility beyond cardiac applications. The study highlighted the ease of use in endovascular treatments and target vessel cannulation in branched and fenestrated aortic grafts. However, it is limited by its focus on non-cardiac applications, which may not directly translate to typical cardiac electrophysiology use cases.
Frequently Asked Questions
What is the HeartSpan Steerable Sheath Introducer used for?
It is used to facilitate catheter access during cardiac electrophysiological procedures, such as ablations for arrhythmias.
What specialties typically use this device?
Interventional cardiologists and electrophysiologists commonly use this device in cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating catheter access in cardiac electrophysiological procedures, particularly for precise placement within the heart.
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.