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implantable pacing leads implantable accessory non-implantable accessory
Intermedics
Summary: Implantable pacing leads by Intermedics are used in cardiac rhythm management. Cleared by FDA via 510k pathway. Studies highlight potential magnetic interference and procedural innovations.
FDA Clearance Information
Pathway
510K
Number
K960281 ↗
Decision Date
June 18, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable pacing leads by Intermedics were cleared by the FDA under the 510k pathway on June 18, 1996. They are classified as Class 3 medical devices.
What It Is
Implantable pacing leads are devices used to deliver electrical impulses to the heart to maintain an adequate heart rate. They are essential in managing arrhythmias and are implanted in conjunction with pacemakers.
Clinical Applications
These leads are commonly used in patients with bradycardia or heart block to ensure proper cardiac pacing. They are also utilized in conjunction with implantable cardioverter-defibrillators (ICDs) for comprehensive cardiac rhythm management.
Evidence Summary
The literature includes 12 studies, ranging from 2011 to 2025, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies explore device interactions and procedural advancements.
Reported Outcomes
Published studies report that implantable pacing leads effectively manage cardiac arrhythmias and maintain heart rhythm. They also highlight the potential for magnetic interference from common electronic devices, which could inadvertently activate magnet mode in certain ICDs.
Safety Profile
Reported complications include the risk of unintended pacing due to magnetic interference from electronic devices, which may lead to discomfort or arrhythmias. No other specific adverse events are detailed in the provided studies.
Evidence Limitations
The evidence is limited by the lack of large-scale, long-term studies specifically focused on the safety and efficacy of these leads. Further research is needed to explore the full range of potential interactions with modern electronic devices.
Frequently Asked Questions
What are the clinical indications for implantable pacing leads?
Implantable pacing leads are indicated for patients requiring cardiac rhythm management, particularly those with bradycardia or heart block.
What outcomes have been reported in clinical studies?
Studies report effective management of arrhythmias and highlight potential magnetic interference issues with electronic devices.
What complications have been reported?
Safety data indicate potential complications from magnetic interference, leading to unintended pacing and possible 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.