đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as an endocardial lead for ventricular cardiac pacing in patients who require electrical pacing support.
- Use in a bipolar pacing system to deliver stimulation to the myocardium.
Clinical Applications
- Ventricular pacing as part of an implanted pacemaker system.
- Endocardial cardiac stimulation when a bipolar pacing lead is indicated.
- Placement in the heart under imaging and electrophysiologic guidance as determined by the treating cardiac specialist.
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.
Practical Considerations
- The record provided does not specify lead length, diameter, fixation mechanism, connector standard, or other size options; these details should be confirmed in the original labeling or device documentation.
- Compatibility with the pulse generator, connector, introducer, and other implanted components must be verified before use.
- The lead is implanted through the venous system into the heart and requires sterile technique, imaging, and cardiac monitoring.
- MRI safety cannot be determined from the available FDA record. Do not assume the lead is MRI-conditional; evaluate the complete implanted system and current manufacturer labeling.
- Potential complications of endocardial pacing leads include infection, venous thrombosis, lead dislodgement or fracture, arrhythmia, perforation, bleeding, and device malfunction.
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.