đź“Š Evidence-Based Reference
passive plus pacing leads with titanium nitride coating
Pacesetter
Summary: Passive plus pacing leads with titanium nitride coating are used in cardiac pacing. They are primarily indicated for bradyarrhythmias. Key evidence highlights their application in both human and veterinary settings.
FDA Clearance Information
Pathway
510K
Number
K951950 ↗
Decision Date
August 31, 1995
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The passive plus pacing leads by Pacesetter were cleared through the FDA 510(k) pathway on August 31, 1995. They are classified as Class 3 devices under product code DTB.
What It Is
Passive plus pacing leads are cardiac pacing devices coated with titanium nitride to enhance conductivity and reduce lead impedance. They are intended for use in patients requiring cardiac pacing due to bradyarrhythmias.
Clinical Applications
These leads are commonly used in scenarios requiring long-term cardiac pacing, such as in patients with symptomatic bradycardia. They are also utilized in veterinary medicine for similar indications.
Evidence Summary
The literature includes a mix of retrospective reviews and clinical trials, with a total of 7 studies spanning from 2015 to 2018. These studies assess both human and veterinary applications of passive pacing leads.
Reported Outcomes
Published studies report that passive pacing leads are effective in maintaining cardiac rhythm in patients with bradyarrhythmias. In veterinary settings, they have shown favorable outcomes in terms of short-term complications and lead stability.
Safety Profile
Reported complications include infection, lead dislodgement, and penetration, particularly noted in the retrospective review of canine implantations. Long-term follow-up studies suggest stable performance with minimal increase in failure rates.
Evidence Limitations
The evidence is limited by the small number of studies and the inclusion of veterinary data, which may not fully extrapolate to human clinical practice. Further research is needed to assess long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for passive plus pacing leads?
They are indicated for patients with bradyarrhythmias requiring cardiac pacing.
What outcomes have been reported in clinical studies?
Studies report effective rhythm management and low short-term complication rates.
What complications have been reported?
Complications include infection, lead dislodgement, and penetration, particularly in veterinary studies.
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.