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model b bipolar endocardial lead
Cook Pacemaker
Summary: The Model B Bipolar Endocardial Lead is a cardiac device used in pacing systems to deliver electrical impulses to the heart. It is primarily used by cardiologists and electrophysiologists in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K811878 ↗
Decision Date
August 3, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model B Bipolar Endocardial Lead by Cook Pacemaker was cleared through the FDA 510(k) pathway on August 3, 1981. It is classified as a Class III device under product code DTB.
What It Is
The Model B Bipolar Endocardial Lead is a component of a pacemaker system, designed to conduct electrical impulses from the pacemaker to the heart muscle. It features two electrodes that enable bipolar sensing and pacing, which can improve signal clarity and reduce interference. This lead is inserted through the venous system and positioned in the heart's endocardium, typically in the right atrium or ventricle.
Clinical Applications
This device is commonly used in patients with arrhythmias such as bradycardia, where the heart beats too slowly. It is often utilized in hospital settings, particularly in cardiology departments, and is implanted by cardiologists or electrophysiologists. The lead is suitable for a wide range of patients, including those with heart block or sick sinus syndrome.
Indications for Use
The Model B Bipolar Endocardial Lead is indicated for patients who require cardiac pacing due to arrhythmias. It is particularly useful in conditions where the heart's natural pacemaker is not functioning properly, necessitating an artificial pacing system.
Practical Considerations
Clinicians should consider the lead's compatibility with the chosen pacemaker generator. Proper sizing and placement are crucial for optimal performance and patient outcomes. Familiarity with venous access techniques is important for successful implantation.
Frequently Asked Questions
What is the Model B Bipolar Endocardial Lead used for?
It is used to deliver electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac rhythm management.
What are the FDA-cleared indications?
It is indicated for use in patients with arrhythmias requiring cardiac pacing, such as bradycardia or heart block.
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.