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bipolar endocardial pacing lead m 6902
Medtronic Vascular
Summary: The bipolar endocardial pacing lead M 6902 by Medtronic Vascular is used for cardiac pacing. Key evidence highlights its design to avoid tricuspid valve crossing and potential myocardial penetration issues.
FDA Clearance Information
Pathway
510K
Number
K780622 ↗
Decision Date
July 28, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The bipolar endocardial pacing lead M 6902 was cleared by the FDA through the 510(k) pathway on July 28, 1978. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The bipolar endocardial pacing lead M 6902 is a cardiac pacing device designed to provide electrical stimulation to the heart. It is intended for use in patients requiring ventricular pacing, with a focus on minimizing complications associated with traditional pacing leads.
Clinical Applications
This device is commonly used in scenarios requiring ventricular pacing, particularly in patients where avoiding tricuspid valve crossing is beneficial. It is suitable for patients with specific pacing needs that align with its design features.
Evidence Summary
The available literature includes three studies, ranging from 1991 to 2010, covering various aspects of bipolar pacing leads. These studies include randomized controlled trials and evaluations of lead design and performance.
Reported Outcomes
Published studies report that the bipolar endocardial pacing lead M 6902 can achieve synchronous ventricular activation without crossing the tricuspid valve. The co-radial design has been noted for its improved handling and reduced size compared to conventional leads.
Safety Profile
Reported complications include potential myocardial penetration and perforation due to lead stiffness, as highlighted in one study. Another study noted a 7% incidence of high threshold exit block with a specific model.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent data. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for bipolar endocardial pacing lead M 6902?
The device is indicated for patients requiring ventricular pacing, with specific design features to avoid tricuspid valve crossing.
What outcomes have been reported in clinical studies?
Studies report synchronous ventricular activation and improved handling with the co-radial design.
What complications have been reported?
Safety data indicate potential myocardial penetration and a 7% incidence of high threshold exit block in specific models.
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.