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intermedics model 436-07 bipolar model 437-07 unipolar implantable endocardial pacing lead
Intermedics
Summary: The Intermedics Model 436-07 Bipolar and Model 437-07 Unipolar Leads are implantable endocardial pacing leads used in cardiac pacing. They are primarily used by cardiologists for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K955122 ↗
Decision Date
November 4, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on November 4, 1996. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Intermedics Model 436-07 and 437-07 are implantable endocardial pacing leads designed for cardiac pacing. The bipolar model (436-07) and unipolar model (437-07) facilitate electrical conduction between a pacemaker and the heart muscle. These leads are essential components in pacemaker systems, ensuring proper heart rhythm management.
Clinical Applications
These pacing leads are commonly used in cardiac electrophysiology and cardiology settings. They are implanted in patients who require long-term cardiac pacing due to conditions like bradycardia or heart block. Cardiologists and electrophysiologists typically perform these procedures in hospital settings, catering to adult and geriatric populations.
Indications for Use
These leads are indicated for patients requiring cardiac pacing, typically those with slow heart rates or irregular heart rhythms. They are used to maintain adequate heart rate and rhythm in patients with conditions like atrioventricular block or sick sinus syndrome.
Practical Considerations
The leads come in different lengths to accommodate various patient anatomies and are compatible with most pacemaker devices. Implantation requires careful consideration of lead positioning and fixation to ensure optimal performance and longevity.
Frequently Asked Questions
What is Intermedics Model 436-07/437-07 used for?
These leads are used in cardiac pacing to manage heart rhythm disorders such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices in cardiac rhythm management.
What are the FDA-cleared indications?
These leads are indicated for patients requiring cardiac pacing due to conditions like 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.