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Coronary Sinus Guide and Lateral Vein Introducer Kits
Thomas Medical Products
Summary: The coronary sinus guide and lateral vein introducer kits are used in cardiac procedures to facilitate access to the coronary sinus. Key evidence highlights their role in optimizing cardiac resynchronization therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K120158 ↗
Decision Date ?
August 14, 2012
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on August 14, 2012. It is manufactured by Thomas Medical Products and classified as a Class 2 device.
What It Is
The coronary sinus guide and lateral vein introducer kits are designed to assist in the placement of leads or catheters into the coronary sinus. They are primarily used in procedures such as cardiac resynchronization therapy.
FDA-Cleared Indications
- Facilitate access to the coronary sinus during cardiac procedures.
- Assist with access to lateral or tributary veins of the coronary sinus.
- Provide a pathway for placement of cardiac leads or catheters when coronary venous access is required.
Clinical Applications
- Accessing the coronary sinus during cardiac resynchronization therapy procedures.
- Facilitating placement of a left ventricular pacing lead through the coronary venous system.
- Guiding catheter or lead placement into a lateral coronary vein or other suitable coronary sinus tributary.
- Supporting coronary venous access during selected electrophysiology and cardiac device-implantation procedures.
Evidence Summary
The literature includes 11 studies, comprising case reports, randomized controlled trials, and retrospective analyses, published between 2016 and 2024. These studies explore various aspects of device use and clinical outcomes.
Reported Outcomes
Published studies report that optimal lead placement using these kits is associated with improved cardiac resynchronization therapy outcomes, such as reduced QRS width during biventricular pacing. The evidence suggests a correlation between lead positioning and clinical improvement.
Safety Profile
Reported complications include procedural challenges related to lead placement and potential delays in achieving optimal electrical activation. However, specific adverse events are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies directly addressing safety outcomes. Further research is needed to establish comprehensive safety profiles and to explore long-term clinical benefits.
Practical Considerations
- The kit configuration, introducer length, curve, and inner diameter should be matched to the planned lead or catheter and the patient's coronary venous anatomy.
- Placement is performed under fluoroscopic imaging, usually through venous access selected by the cardiac operator, such as the subclavian, axillary, or cephalic vein.
- The operator must assess for venous stenosis, tortuosity, dissection, perforation, and difficulty engaging the coronary sinus or lateral branches.
- MRI safety depends on the complete implanted system, including the final pacing lead and generator; the temporary introducer kit itself does not determine whether an implanted system is MRI conditional.
- Use is contraindicated or inappropriate when the required venous route cannot safely be accessed or when the patient has a relevant contraindication to the planned cardiac procedure, contrast, or anticoagulation strategy.
Frequently Asked Questions
What are the clinical indications for coronary sinus guide and lateral vein introducer kits?
These kits are indicated for use in procedures requiring access to the coronary sinus, such as cardiac resynchronization therapy.
What outcomes have been reported in clinical studies?
Studies report improved outcomes in cardiac resynchronization therapy, including reduced QRS width during biventricular pacing.
What complications have been reported?
Reported complications include procedural challenges and potential delays in achieving optimal electrical activation, though specific adverse events are not detailed.
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.