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pacing lead model 6991a
Medtronic Vascular
Summary: The pacing lead model 6991a by Medtronic Vascular is a device used for cardiac pacing. It is primarily indicated for conduction system pacing. Key evidence highlights challenges in deployment and potential for tissue trauma.
FDA Clearance Information
Pathway
510K
Number
K772104 ↗
Decision Date
November 28, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The pacing lead model 6991a was cleared through the FDA 510k pathway on November 28, 1977. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The pacing lead model 6991a is designed for cardiac pacing, specifically targeting the conduction system. It is used to maintain heart rhythm by delivering electrical impulses to the heart muscle.
Clinical Applications
Commonly used in scenarios requiring conduction system pacing, such as in patients with bradycardia. It is also applicable in cases where traditional pacing methods are not suitable.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, published between 2023 and 2024. These studies explore the efficacy and safety of the pacing lead in various clinical settings.
Reported Outcomes
Published studies report that the pacing lead model 6991a is effective in achieving conduction system pacing. However, challenges such as lead entanglement and tissue trauma during deployment have been noted. The efficacy in maintaining heart rhythm is supported by systematic reviews and meta-analyses.
Safety Profile
Reported complications include tissue trauma during implantation, potential for bleeding, and device failure. These issues are primarily associated with the physical interaction between the lead and cardiac tissue.
Evidence Limitations
The evidence is limited by the lack of large-scale, multicenter trials. Most studies are single-center reports, and there is a need for further research on long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for pacing lead model 6991a?
The device is indicated for conduction system pacing, particularly in patients with bradycardia or where traditional pacing is unsuitable.
What outcomes have been reported in clinical studies?
Studies report effective pacing with challenges in deployment, such as lead entanglement and tissue trauma.
What complications have been reported?
Safety data indicate potential for tissue trauma, bleeding, and device failure during implantation and retrieval.
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.