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biotronik s ps-endocardial leads
Biotronik, Gmbh &
Summary: Biotronik S PS-Endocardial Leads are used for cardiac pacing. Cleared by FDA via 510k pathway. Key evidence includes studies on cardiac arrhythmias and device efficacy.
FDA Clearance Information
Pathway
510K
Number
K896824 ↗
Decision Date
August 8, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Biotronik S PS-Endocardial Leads were cleared by the FDA through the 510k pathway on August 8, 1990. Manufactured by Biotronik, Gmbh &. Classified as Class 3 medical device.
What It Is
The Biotronik S PS-Endocardial Leads are implantable devices designed for cardiac pacing. They are used to deliver electrical impulses to the heart to maintain an adequate heart rate, especially in patients with arrhythmias.
Clinical Applications
Commonly used in patients requiring cardiac pacing due to arrhythmias or heart block. These leads are integral in managing conditions that affect the heart's electrical conduction system.
Evidence Summary
The literature includes 10 studies, covering a range of study types such as RCTs and retrospective analyses, published between 2024 and 2025. The studies focus on cardiac arrhythmias and device performance.
Reported Outcomes
Published studies report on the effectiveness of the Biotronik S PS-Endocardial Leads in managing ventricular tachycardia and atrial fibrillation. The leads demonstrate high durability and efficacy in maintaining cardiac rhythm.
Safety Profile
Reported complications include issues related to lead placement and potential arrhythmias. Safety data from the studies highlight the importance of careful patient selection and monitoring.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the Biotronik S PS-Endocardial Leads. Further research is needed to assess long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Biotronik S PS-Endocardial Leads?
Indicated for patients requiring cardiac pacing due to arrhythmias or heart block.
What outcomes have been reported in clinical studies?
Studies report high efficacy in managing ventricular tachycardia and atrial fibrillation.
What complications have been reported?
Complications include lead placement issues and potential arrhythmias.
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.