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permanent pacing leads pybj series
Oscor Medical
Summary: The Permanent Pacing Leads PYBJ Series by Oscor Medical are used for cardiac pacing. Cleared by the FDA in 1988, they are primarily indicated for patients requiring permanent cardiac pacing. Key evidence highlights their role in managing reflex syncope and feasibility in His bundle pacing.
FDA Clearance Information
Pathway
510K
Number
K882345 ↗
Decision Date
October 28, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Permanent Pacing Leads PYBJ Series were cleared through the FDA 510(k) pathway on October 28, 1988. Manufactured by Oscor Medical, they are classified as Class III devices under product code DTB.
What It Is
The Permanent Pacing Leads PYBJ Series are medical devices designed for permanent cardiac pacing. They function by delivering electrical impulses to the heart to maintain an adequate heart rate, particularly in patients with bradycardia or other pacing indications.
Clinical Applications
These leads are commonly used in patients requiring long-term cardiac pacing, such as those with bradycardia or heart block. They are also considered in scenarios where physiological pacing, like His bundle pacing, is desired.
Evidence Summary
The available literature includes a variety of study types, such as systematic reviews, meta-analyses, and case series, with a total of 10 studies ranging from 2020 to 2025. These studies explore the efficacy and safety of cardiac pacing using these leads.
Reported Outcomes
Published studies report that cardiac pacing with the PYBJ series leads can effectively manage reflex syncope, particularly in patients with cardioinhibitory phenotypes. His bundle pacing facilitated by these leads has shown feasibility and potential as a physiological pacing alternative.
Safety Profile
Reported complications include late lead dislodgement, particularly in pediatric patients, and challenges associated with temporary pacing using active-fixation leads. Safety profiles vary depending on the specific application and patient population.
Evidence Limitations
The evidence is limited by heterogeneous study outcomes and a lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy, especially in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for permanent pacing leads PYBJ series?
The clinical indications include permanent cardiac pacing in patients with bradycardia, heart block, and other conditions requiring long-term pacing support.
What outcomes have been reported in clinical studies?
Studies have reported effective management of reflex syncope and feasibility in His bundle pacing, with varying outcomes based on patient characteristics.
What complications have been reported?
Safety data indicate potential complications such as late lead dislodgement in pediatric patients and issues with temporary pacing using active-fixation 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.