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poly flex implantable pacing lead
Intermedics
Summary: The Poly Flex Implantable Pacing Lead by Intermedics is a device used in cardiac pacing to help regulate heart rhythms. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K802294 ↗
Decision Date
April 3, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Poly Flex Implantable Pacing Lead was cleared through the FDA 510(k) pathway on April 3, 1985. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Poly Flex Implantable Pacing Lead is a flexible wire that connects a pacemaker to the heart muscle, delivering electrical impulses to maintain a regular heart rhythm. It is designed to be implanted within the heart's chambers and is integral to the function of a pacemaker system. This device is crucial for patients with arrhythmias or heart block, providing consistent electrical stimulation to ensure effective cardiac contractions.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically perform these procedures in hospital settings, often in specialized cardiac care units. The device is suitable for a wide range of patients, including those with congenital heart conditions or those who have developed arrhythmias due to aging or other cardiac diseases.
Indications for Use
The FDA indications for this device include its use in patients who require cardiac pacing due to arrhythmias such as bradycardia or heart block. It is designed to help maintain a regular heart rhythm in patients whose natural pacemaker is not functioning properly.
Practical Considerations
The Poly Flex Implantable Pacing Lead comes in various lengths and configurations to accommodate different patient anatomies and pacing needs. It is compatible with most pacemaker systems and requires careful implantation to ensure proper function and minimize complications. Clinicians should be familiar with the specific handling and insertion techniques for optimal outcomes.
Frequently Asked Questions
What is the Poly Flex Implantable Pacing Lead used for?
It is used to connect a pacemaker to the heart, delivering electrical impulses to regulate heart rhythms in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings, particularly in cardiac care units.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to arrhythmias such as 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.