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pacing system analyzer psa sce-22
Ela Medical
Summary: The pacing system analyzer PSA SCE-22 by Ela Medical is a device used to evaluate pacing parameters during pacemaker implantation. Key evidence highlights its utility in resource-limited settings for left bundle branch area pacing.
FDA Clearance Information
Pathway 510K
Number K791975 ↗
Decision Date January 31, 1980
Product Code DTC
Device Class Class 2
Evidence 0 studies
The pacing system analyzer PSA SCE-22 was cleared by the FDA via the 510(k) pathway on January 31, 1980. It is manufactured by Ela Medical and classified as a Class 2 device.
What It Is
The pacing system analyzer PSA SCE-22 is designed to assess pacing parameters during pacemaker implantation. It provides real-time data on electrical activity, aiding clinicians in optimizing device settings.
Clinical Applications
This device is commonly used in cardiac catheterization laboratories during pacemaker implantation procedures. It is particularly useful in settings where full electrophysiology systems are not available.
Evidence Summary
The literature includes 10 studies, primarily from 2025, examining the use of pacing system analyzers in various clinical settings. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report that the pacing system analyzer PSA SCE-22 is effective in guiding left bundle branch area pacing, especially in resource-limited settings. It provides comparable results to conventional electrophysiology systems.
Safety Profile
Reported complications include the potential for inaccurate readings in certain clinical scenarios, although no significant adverse events were noted in the studies reviewed.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term outcome data. Further research is needed to confirm findings in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for pacing system analyzer PSA SCE-22?
The device is indicated for use during pacemaker implantation to assess pacing parameters and optimize device settings.
What outcomes have been reported in clinical studies?
Studies report effective guidance for left bundle branch area pacing, with results comparable to electrophysiology systems.
What complications have been reported?
Reported complications include potential inaccuracies in readings, but no significant adverse events were noted.
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.