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permanent pacing leads modification
Oscor Medical
Summary: Permanent pacing leads modification by Oscor Medical is used in cardiac pacing procedures. It is FDA 510k cleared. Key evidence highlights its use in various cardiac scenarios with a focus on safety and efficacy.
FDA Clearance Information
Pathway
510K
Number
K915007 ↗
Decision Date
January 27, 1992
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The permanent pacing leads modification by Oscor Medical was cleared through the FDA 510k pathway on January 27, 1992. It is classified as a Class 3 device.
What It Is
The permanent pacing leads modification is a device used in cardiac pacing procedures to modify or replace existing pacing leads. It is intended for use in patients requiring permanent cardiac pacing.
Clinical Applications
This device is commonly used in scenarios where patients require modification of existing pacing leads due to complications or the need for improved pacing efficacy. It is particularly relevant in cases of lead malfunction or upgrade of pacing systems.
Evidence Summary
The available literature includes 9 studies, comprising various study types such as RCTs, case series, and retrospective analyses. The studies span from 2005 to 2019, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the permanent pacing leads modification is effective in improving pacing outcomes in patients with existing lead complications. The device has been shown to facilitate successful pacing in challenging clinical scenarios, such as when traditional venous access is not feasible.
Safety Profile
Reported complications include issues related to lead placement and potential interactions with other medical procedures, such as electrosurgery and imaging. However, the overall safety profile is considered acceptable within the context of its clinical use.
Evidence Limitations
The evidence is limited by the variability in study designs and the relatively small sample sizes in some studies. Further research is needed to explore long-term outcomes and to establish standardized protocols for its use in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for permanent pacing leads modification?
The device is indicated for patients requiring modification or replacement of existing pacing leads, particularly in cases of lead malfunction or the need for system upgrades.
What outcomes have been reported in clinical studies?
Studies report improved pacing outcomes and successful lead modifications in patients with existing lead complications, enhancing overall cardiac function.
What complications have been reported?
Safety data indicate potential complications related to lead placement and interactions with other medical procedures, though these are generally manageable within clinical settings.
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.