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poly flex implantable pacing lead
Intermedics
Summary: The Poly Flex Implantable Pacing Lead by Intermedics is a medical device used for cardiac pacing. It is typically utilized by cardiologists for patients requiring heart rhythm management.
FDA Clearance Information
Pathway
510K
Number
K802295 ↗
Decision Date
February 9, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Poly Flex Implantable Pacing Lead was cleared via the FDA 510k pathway on February 9, 1981. It is manufactured by Intermedics and classified as a Class III device.
What It Is
The Poly Flex Implantable Pacing Lead is a device designed to deliver electrical impulses to the heart to maintain an adequate heart rate in patients with arrhythmias. It consists of a flexible lead that connects to a pacemaker, ensuring reliable transmission of electrical signals. This device is crucial for patients who have bradycardia or other conditions that affect the heart's ability to maintain a regular rhythm.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in settings such as hospitals and specialized cardiac care centers. It is essential for procedures involving the implantation of pacemakers, often in patients with symptomatic bradycardia or heart block. The device is suitable for adult and elderly populations who are more likely to experience these cardiac conditions.
Indications for Use
The FDA indications for the Poly Flex Implantable Pacing Lead include use in patients who require pacing due to heart rhythm disorders. This typically involves individuals with conditions like bradycardia, where the heart beats too slowly, or heart block, where the electrical signals are partially or completely blocked.
Practical Considerations
When using the Poly Flex Implantable Pacing Lead, clinicians should consider the appropriate lead length and compatibility with the chosen pacemaker. Proper implantation technique is crucial to ensure optimal device function and patient safety. Regular follow-up is necessary to monitor device performance and patient condition.
Frequently Asked Questions
What is the Poly Flex Implantable Pacing Lead used for?
It is used for cardiac pacing in patients with heart rhythm disorders such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring pacing due to heart rhythm disorders, 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.