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model 435-02 cardifix implantable pacing lead
Intermedics
Summary: The Model 435-02 Cardifix is an implantable pacing lead by Intermedics, primarily used for cardiac pacing. Key evidence highlights its role in managing pacing-induced cardiomyopathy and compares physiological pacing strategies.
FDA Clearance Information
Pathway
510K
Number
K862276 ↗
Decision Date
July 2, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 435-02 Cardifix Implantable Pacing Lead was cleared by the FDA via the 510(k) pathway on July 2, 1986. It is manufactured by Intermedics and classified as a Class III device.
What It Is
The Model 435-02 Cardifix is an implantable pacing lead designed for cardiac pacing. It is used to deliver electrical impulses to the heart to maintain an adequate heart rate, particularly in patients with bradycardia or heart block.
Clinical Applications
This device is commonly used in patients requiring cardiac pacing due to conditions like bradycardia or heart block. It is implanted to ensure proper heart rhythm and prevent complications associated with slow heart rates.
Evidence Summary
The available literature includes 10 studies, comprising systematic reviews, meta-analyses, and experimental models, published between 2021 and 2023. These studies explore pacing-induced cardiomyopathy and compare different pacing techniques.
Reported Outcomes
Published studies report that pacing-induced cardiomyopathy is a potential complication of right ventricular pacing. His bundle pacing and left bundle branch pacing are compared for their efficacy in synchronously activating the ventricles, with varying clinical results.
Safety Profile
Reported complications include pacing-induced cardiomyopathy, which can lead to heart failure. The studies highlight the need for careful patient selection and monitoring to mitigate these risks.
Evidence Limitations
The evidence is limited by variability in study definitions and methodologies, particularly concerning pacing-induced cardiomyopathy. Further research is needed to establish standardized definitions and optimal management strategies.
Frequently Asked Questions
What are the clinical indications for Model 435-02 Cardifix Implantable Pacing Lead?
The clinical indications are detailed in the FDA documentation, primarily for patients requiring cardiac pacing due to bradycardia or heart block.
What outcomes have been reported in clinical studies?
Studies report outcomes related to pacing-induced cardiomyopathy and compare physiological pacing strategies like His bundle pacing and left bundle branch pacing.
What complications have been reported?
Safety data indicate complications such as pacing-induced cardiomyopathy, which can lead to heart failure if not properly managed.
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.