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passive plus pacing leads with titanium nitride coating
Pacesetter
Summary: Passive plus pacing leads with titanium nitride coating by Pacesetter are used in cardiac pacing. Key evidence highlights their application in managing bradyarrhythmias with a focus on procedural outcomes and long-term performance.
FDA Clearance Information
Pathway
510K
Number
K952206 ↗
Decision Date
August 31, 1995
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The passive plus pacing leads were cleared by the FDA via the 510(k) pathway on August 31, 1995. Manufactured by Pacesetter, they are classified as Class III devices.
What It Is
The passive plus pacing leads are cardiac pacing leads coated with titanium nitride, designed to enhance electrical performance and reduce lead-related complications. They are intended for use in patients requiring cardiac pacing.
Clinical Applications
These leads are commonly used in the management of bradyarrhythmias, where they help maintain adequate heart rates. They are particularly utilized in scenarios requiring reliable long-term pacing solutions.
Evidence Summary
The literature includes 7 studies, comprising retrospective reviews and clinical trials, focusing on the performance and safety of passive fixation leads. The studies span from 2015 to recent years, providing a comprehensive overview of their clinical application.
Reported Outcomes
Published studies report that passive fixation leads demonstrate satisfactory long-term performance with low failure rates. In canine models, short-term complications and dislodgement rates were evaluated, indicating overall positive procedural outcomes.
Safety Profile
Reported complications include infection and dislodgement, as observed in retrospective reviews. Long-term studies suggest that passive leads may have a lower risk of failure compared to active fixation leads.
Evidence Limitations
The evidence is limited by the retrospective nature of some studies and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and comparative effectiveness in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for passive plus pacing leads?
Passive plus pacing leads are indicated for patients requiring cardiac pacing, particularly in the management of bradyarrhythmias.
What outcomes have been reported in clinical studies?
Studies report satisfactory long-term performance with low failure rates and positive procedural outcomes in managing bradyarrhythmias.
What complications have been reported?
Safety data indicate potential complications such as infection and lead dislodgement, with passive leads showing a lower risk of failure compared to active leads.
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.