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Biotronik
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
510K
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.
Clinical Applications
This device is commonly used in the management of bradycardia, where the heart beats too slowly. It is typically utilized in settings such as cardiac catheterization labs or during surgical procedures in hospitals. Cardiologists and electrophysiologists are the primary specialists who implant these leads in patients requiring pacemaker therapy.
Indications for Use
The FDA indications for the Merox Bipolar High Impedance Lead involve its use in patients who require pacing support due to arrhythmias such as bradycardia. It is suitable for individuals who need long-term pacing therapy.
Practical Considerations
The Merox leads come in various lengths to accommodate different patient anatomies and are compatible with most modern pacemaker systems. Proper placement and secure fixation are crucial for optimal performance and longevity of the device.
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.