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Attain Lds 6216a Left Heart Delivery System Attain Access 6218a Left Heart Delivery System Attain 6216a and 6218a Guid
Summary: The Attain LDS 6216A and 6218A are left heart delivery systems used in cardiac procedures to facilitate the placement of leads in the left heart. They are primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K112917 ↗
Decision Date ?
October 27, 2011
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Attain LDS 6216A and 6218A were cleared through the FDA 510(k) pathway on October 27, 2011. Manufactured by Medtronic, these devices are classified as Class 2 under product code DQY.
What It Is
The Attain LDS 6216A and 6218A are specialized delivery systems designed to assist in the placement of cardiac leads within the left side of the heart. These systems provide a pathway through the venous system to reach the target site, ensuring precise lead placement. The devices are essential in procedures requiring accurate navigation and positioning in the heart's complex anatomy.
FDA-Cleared Indications
- Provide a delivery pathway for placing cardiac leads in the left-heart region.
- Assist with catheter-based navigation through the venous system during cardiac lead placement.
- Use in procedures requiring delivery and positioning of a cardiac lead near the left ventricle.
Clinical Applications
- Delivery of left-ventricular leads for cardiac resynchronization therapy.
- Catheter-based access and navigation toward the coronary sinus and its branches.
- Placement of cardiac leads in patients undergoing an indicated cardiac implant procedure.
- Use in electrophysiology laboratories or cardiac catheterization laboratories for lead-delivery procedures.
Practical Considerations
- The 6216A and 6218A are different delivery-system configurations; clinicians should confirm the selected model, dimensions and compatibility with the planned cardiac lead before use.
- The system is advanced through venous access toward the right atrium and coronary sinus; knowledge of coronary venous anatomy and fluoroscopic technique is required.
- Device handling should follow the current Medtronic instructions for use, including preparation, guidewire or catheter compatibility and limits on advancement or manipulation.
- MRI eligibility applies to the complete implanted cardiac system, not to the delivery catheter alone. The delivery system is removed after lead placement and should not be treated as an implanted MRI device.
- Potential complications are related to venous access, catheter manipulation and lead placement, including bleeding, vascular injury, coronary sinus dissection or perforation, arrhythmia and infection.
Frequently Asked Questions
What is the Attain LDS 6216A & 6218A used for?
These devices are used to facilitate the placement of cardiac leads in the left heart, primarily for cardiac resynchronization therapy.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices in cardiac procedures.
What are the FDA-cleared indications?
The devices are indicated for use in delivering cardiac leads to the left heart, particularly in patients requiring 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.