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myocardial pacing lead
Medtronic
Summary: The Medtronic myocardial pacing lead is a device used for cardiac pacing, primarily in patients requiring cardiac resynchronization therapy. Key evidence highlights its use in cases where transvenous placement is not feasible.
FDA Clearance Information
Pathway
PMA
Number
P120017 ↗
Decision Date
June 14, 2023
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic myocardial pacing lead received FDA clearance through the PMA pathway on June 14, 2023. It is classified as a Class 3 device.
What It Is
The myocardial pacing lead is a device designed for cardiac pacing, used to maintain adequate heart rhythm. It is intended for patients who require cardiac resynchronization therapy, especially when traditional transvenous lead placement is not possible.
Clinical Applications
This device is commonly used in patients with congestive heart failure who need cardiac resynchronization therapy. It is particularly useful in cases with anatomical abnormalities or complications with traditional lead placement.
Evidence Summary
The literature includes 11 studies, ranging from randomized controlled trials to case series, conducted between 1993 and 2021. These studies evaluate the efficacy and safety of myocardial pacing leads in various clinical scenarios.
Reported Outcomes
Published studies report that myocardial pacing leads are effective in providing cardiac resynchronization therapy, improving symptoms and survival in heart failure patients. The device is also noted for its utility in cases where traditional lead placement is challenging.
Safety Profile
Reported complications include lead perforation, migration, and unintended stimulation of adjacent structures. These events highlight the importance of careful surgical technique and patient selection.
Evidence Limitations
The evidence is limited by the small sample sizes and retrospective nature of some studies. Further research is needed to evaluate long-term outcomes and optimize patient selection criteria.
Frequently Asked Questions
What are the clinical indications for myocardial pacing lead?
The device is indicated for patients requiring cardiac resynchronization therapy, particularly when traditional transvenous lead placement is not feasible.
What outcomes have been reported in clinical studies?
Studies report improved symptoms and survival in heart failure patients, with effective cardiac resynchronization therapy provided by the device.
What complications have been reported?
Safety data indicate complications such as lead perforation, migration, and unintended stimulation of adjacent structures.
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.