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attain lds 6216 left-heart delivery system
Medtronic Vascular
Summary: The Attain LDS 6216 is a left-heart delivery system used for placing leads in the left side of the heart. It is primarily used by cardiologists during cardiac resynchronization therapy (CRT) procedures.
FDA Clearance Information
Pathway
510K
Number
K012130 ↗
Decision Date
August 28, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain LDS 6216 was cleared through the FDA 510(k) pathway on August 28, 2001. Manufactured by Medtronic Vascular, it is classified as a Class 2 device under product code DQY.
What It Is
The Attain LDS 6216 is a delivery system designed for the precise placement of cardiac leads in the left side of the heart. It consists of a catheter system that facilitates the navigation through the venous system to the heart. This device is crucial in procedures requiring the placement of pacing leads for cardiac resynchronization therapy, which helps manage heart failure by coordinating the heart's contractions.
Clinical Applications
This device is commonly used in electrophysiology labs by cardiologists specializing in heart failure management. It is employed during cardiac resynchronization therapy (CRT) procedures, which are conducted in hospital settings. The typical patient population includes those with heart failure and left bundle branch block, where synchronized pacing can significantly improve cardiac function.
Indications for Use
The Attain LDS 6216 is indicated for use in patients requiring cardiac resynchronization therapy. It is specifically designed for the placement of leads in the left side of the heart, which is essential for patients with heart failure who benefit from synchronized cardiac pacing.
Practical Considerations
The Attain LDS 6216 is compatible with a range of lead sizes and is designed for ease of navigation through the venous system. Clinicians should be familiar with the anatomy of the coronary sinus and have experience in lead placement techniques to optimize outcomes.
Frequently Asked Questions
What is the Attain LDS 6216 used for?
The Attain LDS 6216 is used for placing cardiac leads in the left side of the heart during cardiac resynchronization therapy.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and heart failure management, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in cardiac resynchronization therapy, specifically for placing leads in the left side of the heart 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.