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easytrak guiding catheter
Guidant
Summary: The easytrak guiding catheter is a medical device used for transvenous left ventricular pacing, primarily in patients with chronic heart failure. It is typically utilized by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K021284 ↗
Decision Date
May 2, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The easytrak guiding catheter was cleared through the FDA 510(k) pathway on May 2, 2002. It is manufactured by Guidant and classified as a Class 2 device under product code DQY.
What It Is
The easytrak guiding catheter is designed to facilitate the placement of pacing leads in the coronary sinus for left ventricular pacing. It is a specialized catheter that allows for precise navigation through the venous system to deliver pacing therapy to the left ventricle. This device is crucial in the management of heart failure, offering an alternative to traditional epicardial lead placement.
Clinical Applications
This device is commonly used in cardiac electrophysiology procedures, particularly for patients requiring cardiac resynchronization therapy (CRT). It is typically employed in hospital catheterization labs by cardiologists and electrophysiologists. The patient population includes those with heart failure who have not responded adequately to conventional treatments and require biventricular pacing.
Indications for Use
The easytrak guiding catheter is indicated for use in patients with chronic heart failure who need left ventricular pacing. It is particularly beneficial for those who require precise lead placement in the coronary sinus to achieve optimal cardiac resynchronization.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and is compatible with standard pacing leads. Clinicians should be familiar with coronary sinus anatomy and have experience in transvenous pacing techniques to ensure successful lead placement.
Related Literature
The linked study explored the initial experiences with a new transvenous electrode for left ventricular stimulation via the coronary sinus. It highlighted the potential of this approach in improving outcomes for heart failure patients requiring biventricular pacing. However, the study was limited by its early stage and small sample size, necessitating further research to confirm its findings.
Frequently Asked Questions
What is easytrak guiding catheter used for?
The easytrak guiding catheter is used for placing pacing leads in the coronary sinus for left ventricular pacing in patients with heart failure.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings, particularly in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for transvenous left ventricular pacing in patients with chronic heart failure who require cardiac resynchronization therapy.
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.