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endocardial atrial pacing lead m 6994
Medtronic Vascular
Summary: The endocardial atrial pacing lead M 6994 by Medtronic Vascular is a device used for cardiac pacing. It was FDA-cleared via the 510k pathway in 1978. Key evidence includes studies on pacing system malfunctions and comparisons with other pacing techniques.
FDA Clearance Information
Pathway
510K
Number
K780623 ↗
Decision Date
July 28, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The endocardial atrial pacing lead M 6994 was cleared by the FDA through the 510k pathway on July 28, 1978. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The endocardial atrial pacing lead M 6994 is designed for cardiac pacing, specifically targeting the atrial chamber of the heart. It is intended to manage arrhythmias by delivering electrical impulses to maintain a regular heart rhythm.
Clinical Applications
This device is commonly used in patients requiring atrial pacing due to conditions like atrial fibrillation or bradycardia. It is particularly useful in scenarios where maintaining atrial contraction is crucial for cardiac function.
Evidence Summary
The available literature includes six studies ranging from case reports to randomized clinical trials. These studies span from 1997 to 2020, focusing on various aspects of pacing lead performance and outcomes.
Reported Outcomes
Published studies report that the endocardial atrial pacing lead M 6994 is effective in maintaining cardiac rhythm in patients with atrial arrhythmias. Some studies highlight its role in improving clinical status in patients who did not respond to conventional therapies.
Safety Profile
Reported complications include potential malfunctions due to external factors like electrical discharges. However, specific adverse events related to the device itself are not extensively documented in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized trials. Further research is needed to fully understand the long-term safety and efficacy of the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for endocardial atrial pacing lead M 6994?
The device is indicated for patients requiring atrial pacing, particularly in cases of atrial fibrillation or bradycardia.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of cardiac rhythm and improved clinical status in non-responders to conventional therapies.
What complications have been reported?
Reported complications include potential malfunctions due to external electrical discharges, with limited data on other adverse events.
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.