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polyflex implantable pacing lead
Intermedics
Summary: The Polyflex Implantable Pacing Lead is a cardiac device used to deliver electrical impulses to the heart. It is primarily used by cardiologists for patients requiring pacing support.
FDA Clearance Information
Pathway
510K
Number
K802293 ↗
Decision Date
October 31, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Polyflex Implantable Pacing Lead was cleared through the FDA 510k pathway on October 31, 1980. Manufactured by Intermedics, this device is classified as Class III under product code DTB.
What It Is
The Polyflex Implantable Pacing Lead is a medical device designed to provide electrical stimulation to the heart, ensuring proper heart rhythm in patients with arrhythmias. It consists of a flexible lead that connects to a pacemaker, transmitting electrical impulses to the heart muscle. This device is crucial for patients with bradycardia or other conduction disorders.
Clinical Applications
Commonly used in cardiology, this device is implanted in patients who require long-term pacing support due to conditions like heart block or sick sinus syndrome. It is typically used in hospital settings, particularly in cardiac catheterization labs or during surgical procedures. The patient population includes adults and elderly patients with chronic heart rhythm issues.
Indications for Use
The device is indicated for patients who need cardiac pacing due to arrhythmias such as bradycardia. It helps maintain an adequate heart rate, especially in those with heart block or other conduction system diseases.
Practical Considerations
The Polyflex Implantable Pacing Lead is compatible with most pacemaker systems. Clinicians should be aware of the lead's length and diameter to ensure proper fit and function. Proper implantation technique is crucial to avoid lead dislodgement or malfunction.
Frequently Asked Questions
What is the Polyflex Implantable Pacing Lead used for?
It is used to provide electrical stimulation to the heart in patients with arrhythmias, ensuring proper heart rhythm.
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 patients requiring cardiac pacing due to arrhythmias 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.