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cook vascular serpenta coronary sinus introducer system
Cook Vascular
Summary: The Cook Vascular Serpenta Coronary Sinus Introducer System is a device used for introducing leads or catheters into the coronary sinus. It is primarily used in cardiac resynchronization therapy. Key evidence highlights its application in both successful and challenging CRT cases.
FDA Clearance Information
Pathway
510K
Number
K023937 ↗
Decision Date
May 27, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cook Vascular Serpenta Coronary Sinus Introducer System was cleared by the FDA through the 510(k) pathway on May 27, 2003. It is manufactured by Cook Vascular and classified as a Class 2 device.
What It Is
The Cook Vascular Serpenta Coronary Sinus Introducer System is designed to facilitate the introduction of leads or catheters into the coronary sinus. It is used in procedures such as cardiac resynchronization therapy, where precise placement of leads is critical.
Clinical Applications
This device is commonly used in cardiac resynchronization therapy, particularly in patients with heart failure who require precise lead placement in the coronary sinus. It is also utilized in scenarios where anatomical challenges make lead placement difficult.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs, prospective, and retrospective studies. The studies span from 2017 to 2024, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the device facilitates successful lead placement in cardiac resynchronization therapy, even in patients with previously failed CRT or anatomical challenges. The outcomes indicate improved procedural success rates and potential enhancements in patient management.
Safety Profile
Reported complications include challenges related to anatomical variations and procedural complexities. However, the studies suggest that the device's design helps mitigate some of these risks, contributing to overall procedural safety.
Evidence Limitations
The evidence is limited by the variability in study designs and patient populations. Further research is needed to explore long-term outcomes and to validate findings across diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Cook Vascular Serpenta Coronary Sinus Introducer System?
The device is indicated for use in cardiac resynchronization therapy, particularly in patients with heart failure requiring lead placement in the coronary sinus.
What outcomes have been reported in clinical studies?
Studies report successful lead placement and improved procedural success rates, even in challenging anatomical scenarios.
What complications have been reported?
Reported complications include issues related to anatomical variations and procedural complexities, though the device design helps mitigate some risks.
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.