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ccs model sj-103 implantable atrial
Cardiac Control Systems
Summary: The CCS Model SJ-103 is an implantable atrial device designed for cardiac rhythm management. It is primarily used to manage atrial tachyarrhythmias. Key evidence highlights its role in reducing atrial tachyarrhythmias.
FDA Clearance Information
Pathway
510K
Number
K831529 ↗
Decision Date
June 30, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The CCS Model SJ-103 was cleared through the FDA 510(k) pathway on June 30, 1983. Manufactured by Cardiac Control Systems, it is classified as a Class III device.
What It Is
The CCS Model SJ-103 is an implantable device used for managing atrial tachyarrhythmias. It functions by delivering electrical impulses to the atria to maintain normal heart rhythm, particularly in patients with atrial fibrillation or flutter.
Clinical Applications
This device is commonly used in patients with atrial fibrillation or atrial flutter to prevent arrhythmia episodes. It is particularly beneficial in scenarios where pharmacological interventions are insufficient.
Evidence Summary
The available literature includes three studies, with publication years ranging from 2020 to 2023. These studies encompass various methodologies, including retrospective and prospective analyses.
Reported Outcomes
Published studies report that the CCS Model SJ-103 is effective in reducing episodes of atrial tachyarrhythmias. The device's reactive atrial-based antitachycardia pacing therapy has shown promise in terminating atrial fibrillation episodes when they organize into atrial flutter or tachycardia.
Safety Profile
Reported complications include the potential for device-related infections and lead dislodgement. However, specific safety data from the provided studies are limited, necessitating further investigation.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to establish long-term efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for CCS Model SJ-103?
The device is indicated for patients with atrial tachyarrhythmias, such as atrial fibrillation or flutter, particularly when other treatments are inadequate.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in atrial tachyarrhythmia episodes, with reactive atrial-based pacing showing effectiveness in terminating arrhythmias.
What complications have been reported?
Reported complications include device-related infections and lead dislodgement, though specific safety data are limited.
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.