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scoutpro 7f coronary sinus lead delivery system
Biotronik
Summary: The scoutpro 7f Coronary Sinus Lead Delivery System by Biotronik is a medical device used to facilitate the placement of leads in the coronary sinus for cardiac resynchronization therapy. It is primarily used by cardiologists in interventional cardiology settings.
FDA Clearance Information
Pathway
510K
Number
K060807 ↗
Decision Date
April 24, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The scoutpro 7f was cleared through the FDA 510(k) pathway on April 24, 2006. Manufactured by Biotronik, it is classified as a Class 2 device under product code DQY.
What It Is
The scoutpro 7f Coronary Sinus Lead Delivery System is designed to assist in the placement of pacing leads within the coronary sinus. It consists of a catheter system that provides access to the venous system of the heart, allowing for precise lead placement. This device is crucial for procedures involving cardiac resynchronization therapy, which is used to treat heart failure by improving the coordination of the heart's contractions.
Clinical Applications
This device is commonly used in interventional cardiology, particularly in procedures involving cardiac resynchronization therapy (CRT). It is employed in hospital settings, often in catheterization labs, to aid in the delivery of leads to the coronary sinus. The primary patient population includes individuals with heart failure who require CRT to improve cardiac function and quality of life.
Indications for Use
The scoutpro 7f is indicated for use in patients requiring cardiac resynchronization therapy, particularly those with heart failure. It facilitates the placement of leads in the coronary sinus, which is essential for effective CRT.
Practical Considerations
The device is typically compatible with standard pacing leads and is designed for use with a 7 French catheter. Clinicians should be familiar with venous anatomy and have experience in lead placement techniques to ensure successful outcomes.
Frequently Asked Questions
What is scoutpro 7f Coronary Sinus Lead Delivery System used for?
It is used for placing leads in the coronary sinus during cardiac resynchronization therapy.
What specialties typically use this device?
Interventional cardiologists typically use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in cardiac resynchronization therapy for patients with heart failure.
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.