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intermedics poly flex endocardial pacing
Intermedics
Summary: The Intermedics Poly Flex Endocardial Pacing device is used for cardiac pacing. It is typically utilized by cardiologists in managing patients with arrhythmias requiring pacing support.
FDA Clearance Information
Pathway
510K
Number
K811106 ↗
Decision Date
May 27, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics Poly Flex Endocardial Pacing device was cleared through the FDA 510k pathway on May 27, 1981. It is manufactured by Intermedics and classified as a Class III device.
What It Is
The Intermedics Poly Flex Endocardial Pacing device is a cardiac pacing lead designed for endocardial implantation. It functions by delivering electrical impulses to the heart to maintain an adequate heart rate in patients with arrhythmias. The device is typically used in conjunction with a pacemaker generator to provide pacing therapy.
Clinical Applications
This device is commonly used in cardiology, particularly in hospital settings where patients require cardiac pacing. It is suitable for patients with bradycardia or other arrhythmias that necessitate pacing. The device is implanted endocardially, meaning it is placed inside the heart, usually in the right atrium or ventricle.
Indications for Use
The device is indicated for patients who need cardiac pacing due to conditions like bradycardia, where the heart beats too slowly. It helps maintain a regular heart rhythm by providing electrical stimulation.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. It is compatible with most pacemaker generators. Clinicians should be familiar with the implantation technique and ensure proper lead placement for optimal performance.
Frequently Asked Questions
What is Intermedics Poly Flex Endocardial Pacing used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias like 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.