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Merox Bipolar High Impedance Lead Models Mex 53 13-bp 60 15-bp 45-jbp 53-jbp
Summary: The Merox Bipolar High Impedance Lead is a cardiac device used in pacing systems to deliver electrical impulses to the heart. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K010281 ↗
Decision Date ?
April 9, 2002
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Merox Bipolar High Impedance Lead by Biotronik was cleared through the FDA's 510(k) pathway on April 9, 2002. It is a Class III device under product code DTB.
What It Is
The Merox Bipolar High Impedance Lead is a specialized lead used in cardiac pacing systems. It is designed to deliver electrical impulses to the heart to maintain an adequate heart rate in patients with arrhythmias. The high impedance design helps to optimize battery life of the pacemaker by reducing the current drain. This lead is typically implanted in the heart's right atrium or ventricle.
FDA-Cleared Indications
- Use as a bipolar, high-impedance pacing lead with a compatible pacemaker system for cardiac pacing.
- Placement in the right atrium or right ventricle when indicated by the patient's pacing therapy.
- Use in patients who require permanent pacing for labeled bradycardia or cardiac rhythm indications.
Clinical Applications
- Permanent atrial or ventricular pacing as part of a compatible pacemaker system.
- Treatment of patients who require pacing support because of clinically significant bradycardia.
- Implantation through a venous access route with fluoroscopic guidance during pacemaker implantation.
- Connection to an implanted pulse generator to sense cardiac activity and deliver pacing impulses.
Practical Considerations
- The listed models have different lead configurations and lengths; the implanting clinician selects the appropriate model for the patient's anatomy and pacing plan.
- The lead must be connected to a compatible pulse generator and implanted with appropriate fixation, testing and electrical measurements.
- The procedure requires sterile technique, imaging guidance and monitoring for complications such as lead dislodgement, perforation, pneumothorax, infection or bleeding.
- MRI safety depends on the complete implanted system, including the pulse generator, lead combination and labeling; this lead should not be assumed to be MRI-conditional by itself.
- Contraindications and warnings should be reviewed in the manufacturer’s labeling, particularly for active infection, unsuitable venous access, inadequate cardiac tissue for fixation or incompatibility with the planned pacemaker.
Frequently Asked Questions
What is the Merox Bipolar High Impedance Lead used for?
It is used to deliver electrical impulses to the heart in patients requiring pacing support due to arrhythmias like bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in clinical settings such as hospitals and cardiac catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in patients who need pacing support due to arrhythmias, specifically for those with bradycardia.
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.