đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in patients who require cardiac pacing for heart rhythm disorders.
- Use for pacing in patients with symptomatic bradycardia, when the heart rate is too slow.
- Use for pacing in patients with heart block or impaired conduction of electrical signals through the heart.
Clinical Applications
- Connecting an implanted pacemaker to the heart during permanent pacemaker implantation.
- Delivering pacing impulses in patients with clinically significant bradycardia.
- Providing pacing support for patients with partial or complete heart block.
- Supporting long-term heart-rhythm management under cardiology follow-up.
Practical Considerations
- The lead length and configuration must be selected for the patient’s anatomy and the compatible pacemaker generator.
- Implantation requires appropriate venous access, imaging or electrical guidance as clinically indicated, and testing of lead position and function.
- The implanting clinician should review the specific device labeling for connector compatibility, handling instructions, contraindications, and lead performance limits.
- MRI safety cannot be assumed from the device name alone. The lead and pacemaker system should be evaluated as a complete system under current manufacturer and FDA labeling before MRI.
- Long-term follow-up is needed to monitor lead integrity, pacing thresholds, sensing, battery status, and complications such as dislodgment, fracture, infection, or venous obstruction.
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.