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attain select 6238tel guide catheter set for left-heart delivery
Medtronic Vascular
Summary: The Attain Select 6238TEL Guide Catheter Set is designed for left-heart delivery, primarily used in venous stent procedures. Key evidence highlights its feasibility in challenging coronary sinus lead placements.
FDA Clearance Information
Pathway
510K
Number
K042194 ↗
Decision Date
September 15, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Select 6238TEL Guide Catheter Set was cleared via the FDA 510(k) pathway on September 15, 2004. Manufactured by Medtronic Vascular, it is classified as a Class 2 device.
What It Is
The Attain Select 6238TEL Guide Catheter Set is a medical device used for the delivery of leads to the left heart. It facilitates the placement of coronary sinus leads, particularly in complex anatomical scenarios.
Clinical Applications
This device is commonly used in procedures requiring venous stent placement and lead delivery in the left heart, especially in patients with challenging coronary sinus anatomy.
Evidence Summary
The available literature includes 9 studies, comprising various study types such as RCTs and case series, published between 2021 and 2025. These studies explore the device's feasibility and application in clinical settings.
Reported Outcomes
Published studies report the device's effectiveness in facilitating coronary sinus lead placement, particularly in cases with anatomical challenges like persistent left superior vena cava. The device has been shown to expand lead placement options in difficult-to-access coronary sinus branches.
Safety Profile
Reported complications include challenges in lead placement due to anatomical variations, but specific adverse events are not detailed in the provided evidence. Further studies are needed to comprehensively assess safety.
Evidence Limitations
The evidence is limited by the small number of studies focusing on specific anatomical challenges. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Attain Select 6238TEL Guide Catheter Set?
The device is indicated for use in left-heart delivery procedures, particularly for venous stent placement and coronary sinus lead delivery.
What outcomes have been reported in clinical studies?
Studies report successful lead placement in challenging coronary sinus anatomies, expanding options for lead delivery.
What complications have been reported?
Reported complications include difficulties in lead placement due to anatomical variations, with no specific adverse events detailed in the evidence.
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.