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pacemaker lead adapter
Ela Medical
Summary: The pacemaker lead adapter by Ela Medical is a device used to connect pacemaker leads to pulse generators. It is primarily used in scenarios requiring compatibility between different device components. Key evidence highlights its role in facilitating device revisions without disturbing existing components.
FDA Clearance Information
Pathway
510K
Number
K890018 ↗
Decision Date
June 20, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The pacemaker lead adapter by Ela Medical was cleared through the FDA 510(k) pathway on June 20, 1989. It is classified as a Class III medical device.
What It Is
The pacemaker lead adapter is designed to connect pacemaker leads to pulse generators, ensuring compatibility between different components. It is used in cardiac pacing systems to facilitate device revisions and upgrades.
Clinical Applications
This device is commonly used in clinical scenarios where pacemaker lead compatibility is required, such as during generator replacements or upgrades. It helps avoid additional surgical procedures by ensuring seamless integration of new components.
Evidence Summary
The literature includes 11 studies, comprising various study types such as RCTs, case series, and retrospective analyses. The studies span from 1996 to 2026, providing insights into the device's performance and safety.
Reported Outcomes
Published studies report that the pacemaker lead adapter effectively facilitates device revisions, allowing for seamless integration of new components without disturbing existing leads. It has been shown to maintain stable pacing paradigms in experimental models.
Safety Profile
Reported complications include issues related to connector incompatibility, which can lead to additional procedures and increased morbidity. However, the device generally supports safe revisions and upgrades when used appropriately.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of standardized outcome measures. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for pacemaker lead adapter?
The device is indicated for use in scenarios requiring compatibility between pacemaker leads and pulse generators, such as during device revisions or upgrades.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of device revisions and stable pacing paradigms, with successful integration of new components.
What complications have been reported?
Safety data indicate complications related to connector incompatibility, potentially leading to additional procedures and increased morbidity.
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.