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polyflex r epicardial 439-04 implant pacing lead
Intermedics
Summary: The Polyflex R Epicardial 439-04 Implant Pacing Lead is a device used in cardiac pacing, typically by cardiologists or cardiac surgeons. It is designed for epicardial implantation to help manage heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K874531 ↗
Decision Date
January 7, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Polyflex R Epicardial 439-04 Implant Pacing Lead was cleared via the FDA 510(k) pathway on January 7, 1988. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Polyflex R Epicardial 439-04 Implant Pacing Lead is a specialized lead used in cardiac pacing systems. It is designed for epicardial implantation, meaning it is placed on the outer surface of the heart. This lead helps deliver electrical impulses to regulate heart rhythms, particularly in patients with arrhythmias or heart block. Its design ensures reliable performance in the challenging environment of the epicardial space.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly for patients requiring epicardial pacing due to conditions like heart block or bradycardia. It is often utilized in pediatric and adult cardiac surgery, where transvenous lead placement is not feasible or advisable. Cardiologists and cardiac surgeons typically use this device in both elective and emergency procedures.
Indications for Use
The Polyflex R Epicardial 439-04 Implant Pacing Lead is indicated for patients who require pacing support due to heart rhythm disorders. It is particularly useful in cases where transvenous leads are not suitable, such as in patients with congenital heart defects or after certain types of cardiac surgery.
Practical Considerations
The device is available in various lengths to accommodate different patient anatomies and surgical needs. It is compatible with standard pacing generators. Proper surgical technique is crucial for optimal lead placement and function, and clinicians should be trained in epicardial lead implantation.
Frequently Asked Questions
What is Polyflex R Epicardial 439-04 Implant Pacing Lead used for?
It is used for epicardial pacing to manage heart rhythm disorders, especially when transvenous leads are not suitable.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use this device, particularly in surgical settings.
What are the FDA-cleared indications?
It is indicated for patients requiring epicardial pacing support due to heart rhythm disorders or when transvenous leads are not feasible.
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.