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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 ?
510(k)
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.
FDA-Cleared Indications
- Cardiac pacing in patients with symptomatic bradycardia.
- Cardiac pacing for conduction disorders, including heart block.
- Use with a compatible pacemaker system when long-term electrical stimulation of the heart is required.
Clinical Applications
- Implantation as part of a permanent pacemaker system.
- Delivery of electrical impulses to the heart muscle in patients who require pacing support.
- Pacing support for selected patients with bradycardia or heart block.
- Use during a pacemaker implantation procedure in a hospital or cardiac electrophysiology setting.
Practical Considerations
- The lead must be matched to a compatible pacemaker generator and implanted in an appropriate cardiac location.
- Lead length, diameter, connector type and fixation design should be confirmed before implantation.
- Implantation requires imaging and electrical testing to confirm appropriate position, sensing and pacing thresholds.
- Potential complications include lead dislodgement, fracture, insulation failure, infection, bleeding and abnormal heart rhythms.
- MRI safety depends on the complete implanted system and its labeling; this historical lead should not be assumed to be MRI-conditional without verification.
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.