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Model 495-01 Pacing Lead
Intermedics
Summary: The model 495-01 pacing lead by Intermedics is a cardiac pacing device cleared by the FDA. It is primarily used in cardiac pacing procedures. Key evidence highlights its use in various pacing scenarios with a focus on safety and efficacy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K844265 ↗
Decision Date ?
March 28, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The model 495-01 pacing lead was cleared by the FDA via the 510(k) pathway on March 28, 1985. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The model 495-01 pacing lead is a cardiac device designed for pacing the heart. It is used to deliver electrical impulses to the heart muscle to maintain an adequate heart rate, particularly in patients with arrhythmias.
FDA-Cleared Indications
- Cardiac pacing in patients requiring electrical stimulation of the heart.
- Use with a compatible pacemaker system for treatment of clinically significant bradycardia or conduction disturbances.
Clinical Applications
- Transvenous placement of a pacing lead in a cardiac chamber as part of a permanent pacemaker system.
- Pacing patients with symptomatic bradycardia.
- Pacing patients with heart block or other cardiac conduction disturbances.
- Delivery of electrical impulses from an implanted pulse generator to cardiac tissue.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and case series, published between 2022 and 2025. These studies explore the device's application in cardiac pacing and its associated outcomes.
Reported Outcomes
Published studies report that the model 495-01 pacing lead is effective in maintaining cardiac rhythm in patients with arrhythmias. The lead has shown reliability in procedural outcomes and conduction system capture. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include potential lead fractures and issues with lead deployment. While the studies highlight the device's general safety, detailed adverse event rates are not specified in the evidence provided.
Evidence Limitations
The evidence lacks detailed long-term outcome data and specific efficacy metrics. Further research is needed to explore the lead's performance in diverse patient populations and to assess long-term safety and efficacy.
Practical Considerations
- The lead must be matched to a compatible pulse generator and pacing system; connector and electrical specifications should be confirmed before implantation.
- Implantation requires fluoroscopic or other appropriate imaging guidance, sterile technique, and cardiac rhythm monitoring.
- The available lead length, diameter, fixation design, and electrode configuration should be verified in the original labeling or device records before use.
- MRI safety cannot be assumed for this older lead. The complete implanted system must be evaluated against current MRI-conditional requirements; otherwise, MRI may pose risks.
- Potential complications include lead dislodgement, loss of capture, abnormal sensing, infection, venous thrombosis, perforation, and arrhythmia.
Frequently Asked Questions
What are the clinical indications for model 495-01 pacing lead?
The device is indicated for use in patients requiring cardiac pacing due to arrhythmias such as bradycardia or heart block.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of cardiac rhythm and reliable procedural outcomes, though specific metrics are not detailed.
What complications have been reported?
Safety data indicate potential lead fractures and deployment issues, but specific adverse event rates are not provided.
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.