đź“‹ FDA Reference
intermedics poly flex endocardial atrial
Intermedics
Summary: The Intermedics Poly Flex Endocardial Atrial is a cardiac device used primarily in electrophysiology for atrial pacing. It is utilized by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K812245 ↗
Decision Date
October 6, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics Poly Flex Endocardial Atrial was cleared through the FDA 510(k) pathway on October 6, 1981. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Intermedics Poly Flex Endocardial Atrial is a type of cardiac pacing lead designed for endocardial atrial placement. It functions by delivering electrical impulses to the heart's atrium to maintain an adequate heart rate. This device is essential in managing arrhythmias and is typically used in conjunction with pacemakers.
Clinical Applications
This device is commonly used in the management of atrial arrhythmias, such as atrial fibrillation or atrial flutter, where pacing support is required. It is primarily used in cardiology and electrophysiology departments, particularly in hospital settings. Patients who benefit from this device include those with symptomatic bradycardia or those undergoing cardiac surgery.
Indications for Use
The device is indicated for patients requiring atrial pacing due to conditions like atrial fibrillation or flutter. It is suitable for individuals with symptomatic bradycardia or those who have undergone cardiac surgery and need pacing support.
Practical Considerations
The device typically comes in various sizes to accommodate different patient anatomies. It is compatible with most pacemaker systems, but clinicians should verify compatibility before use. Proper technique during insertion is crucial to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Intermedics Poly Flex Endocardial Atrial used for?
It is used for atrial pacing in patients with arrhythmias such as atrial fibrillation or flutter.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for atrial pacing in patients with conditions like atrial fibrillation or flutter, particularly those with symptomatic 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.