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medtronic model 6957
Medtronic Vascular
Summary: The Medtronic Model 6957 is a unipolar screw-in lead used in cardiac pacing. It is primarily used for ventricular pacing. Key evidence highlights its acute pacing threshold performance.
FDA Clearance Information
Pathway
510K
Number
K790429 ↗
Decision Date
July 5, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 6957 was cleared through the FDA 510(k) pathway on July 5, 1979. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic Model 6957 is a unipolar screw-in lead designed for cardiac pacing. It is used to deliver electrical impulses to the heart to maintain an adequate heart rate, particularly in patients with arrhythmias.
Clinical Applications
Commonly used in scenarios requiring ventricular pacing, the Medtronic Model 6957 is suitable for patients with conditions such as sick sinus syndrome or AV block. It is often employed in both acute and chronic pacing settings.
Evidence Summary
The available literature includes four studies, ranging from 1990 to 2026. These studies encompass various designs, including retrospective and prospective analyses, focusing on pacing thresholds and clinical outcomes.
Reported Outcomes
Published studies report that the Medtronic Model 6957 demonstrates an acute ventricular pacing threshold of 0.84 volts with a standard deviation of 0.17. This performance is comparable to other lead types, such as tined leads, which show a threshold of 0.58 volts.
Safety Profile
Reported complications include changes in pacing threshold and R- or P-wave amplitude during implantation. These changes are typically acute and stabilize shortly after the procedure.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Medtronic Model 6957?
The Medtronic Model 6957 is indicated for use in patients requiring ventricular pacing, such as those with sick sinus syndrome or AV block.
What outcomes have been reported in clinical studies?
Clinical studies have reported an acute ventricular pacing threshold of 0.84 volts, indicating effective pacing performance.
What complications have been reported?
Safety data from evidence indicate complications such as acute changes in pacing threshold and R- or P-wave amplitude during implantation.
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.