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poly-flex pacing leads
Intermedics
Summary: Poly-flex pacing leads by Intermedics are used for cardiac pacing. Cleared by FDA via 510k in 1981. Key evidence highlights their role in reducing pacing-induced cardiomyopathy.
FDA Clearance Information
Pathway
510K
Number
K813028 ↗
Decision Date
December 10, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The poly-flex pacing leads were cleared by the FDA through the 510k pathway on December 10, 1981. Manufactured by Intermedics, they are classified as Class 3 medical devices.
What It Is
Poly-flex pacing leads are designed for cardiac pacing, providing electrical stimulation to maintain heart rhythm. They are used in patients requiring pacemaker implantation to manage arrhythmias.
Clinical Applications
These leads are commonly used in scenarios requiring pacemaker implantation, particularly for patients with bradycardia or heart block. They help maintain adequate heart rate and rhythm.
Evidence Summary
The literature includes 9 studies, with a mix of RCTs, prospective, retrospective, and case series designs, spanning from 2022 to 2025. These studies explore various aspects of pacing techniques and outcomes.
Reported Outcomes
Published studies report that poly-flex pacing leads are effective in reducing the risk of pacing-induced cardiomyopathy. They provide reliable pacing thresholds and lower rates of lead dislodgment, contributing to improved cardiac resynchronization.
Safety Profile
Reported complications include pacing-induced cardiomyopathy, particularly with right ventricular pacing. However, left bundle branch area pacing shows promise in mitigating these risks.
Evidence Limitations
The evidence is limited by variability in study designs and definitions of pacing-induced cardiomyopathy. Further research is needed to standardize outcomes and explore long-term safety and efficacy.
Frequently Asked Questions
What are the clinical indications for poly-flex pacing leads?
The clinical indications are detailed in the FDA documentation, primarily for patients requiring cardiac pacing due to arrhythmias.
What outcomes have been reported in clinical studies?
Studies report effective pacing with reduced risk of cardiomyopathy and reliable lead stability.
What complications have been reported?
Safety data indicate risks of pacing-induced cardiomyopathy, particularly with right ventricular pacing.
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.