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attain prevail left heart delivery system moddel 6228sys
Medtronic Vascular
Summary: The Attain Prevail Left Heart Delivery System is a medical device used for the delivery of leads to the left side of the heart, primarily in cardiac resynchronization therapy. It is used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K032622 ↗
Decision Date
September 3, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Prevail Left Heart Delivery System, manufactured by Medtronic Vascular, was cleared by the FDA via the 510(k) pathway on September 3, 2003. It is a Class 2 device under product code DQY.
What It Is
The Attain Prevail Left Heart Delivery System is designed to facilitate the placement of leads in the left heart during procedures such as cardiac resynchronization therapy (CRT). The system includes a catheter and other components that help navigate the venous system to reach the target site in the heart. This device is essential for ensuring precise lead placement, which is crucial for the effective functioning of CRT devices.
Clinical Applications
This device is commonly used in cardiology and electrophysiology to assist in the placement of left ventricular leads for cardiac resynchronization therapy. It is typically utilized in hospital settings, particularly in catheterization labs, by specialists who perform complex cardiac procedures. The patient population includes those with heart failure who require CRT to improve cardiac function and quality of life.
Indications for Use
The FDA indications for the Attain Prevail Left Heart Delivery System involve its use in procedures that require lead placement in the left side of the heart. It is specifically indicated for patients undergoing cardiac resynchronization therapy, which is often used to treat heart failure.
Practical Considerations
Clinicians should be aware of the various sizes and configurations available to match patient anatomy and procedural needs. Compatibility with other cardiac devices and leads should be confirmed prior to use. Proper technique and familiarity with the venous anatomy are essential for successful lead placement.
Frequently Asked Questions
What is the Attain Prevail Left Heart Delivery System used for?
It is used for the delivery and placement of leads in the left heart during cardiac resynchronization therapy.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring lead placement in the left heart, particularly for cardiac resynchronization therapy in heart failure patients.
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.