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laryngeal surface electrode
Spes Medica Srl
Summary: The laryngeal surface electrode by Spes Medica Srl is used for intraoperative nerve monitoring, particularly of the recurrent laryngeal nerve. Key evidence highlights its role in reducing nerve damage during surgeries.
FDA Clearance Information
Pathway
510K
Number
K093373 ↗
Decision Date
August 24, 2010
Product Code
ETN
Device Class
Class 2
Evidence
0 studies
The laryngeal surface electrode was cleared by the FDA via the 510(k) pathway on August 24, 2010. It is manufactured by Spes Medica Srl and classified as a Class 2 device.
What It Is
The laryngeal surface electrode is a device designed for intraoperative monitoring of the recurrent laryngeal nerve. It is used to provide real-time feedback on nerve function during surgeries, such as thyroidectomy, to prevent nerve damage.
Clinical Applications
This device is commonly used in thyroid and parathyroid surgeries, esophagectomies, and other procedures where the recurrent laryngeal nerve is at risk. It aids in reducing the incidence of nerve damage by providing continuous monitoring.
Evidence Summary
The literature includes 14 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, spanning from 2000 to 2024. These studies evaluate the efficacy and safety of the device in various surgical contexts.
Reported Outcomes
Published studies report that the use of the laryngeal surface electrode improves intraoperative nerve monitoring accuracy, potentially reducing the risk of recurrent laryngeal nerve injury. It is particularly effective in surgeries requiring nerve identification and monitoring.
Safety Profile
Reported complications include potential technical difficulties in electrode placement and signal interpretation. However, no significant adverse events directly attributed to the device have been documented in the available studies.
Evidence Limitations
The evidence is limited by the variability in study designs and sample sizes. Further research is needed to standardize monitoring protocols and evaluate long-term outcomes across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for laryngeal surface electrode?
The device is indicated for intraoperative monitoring of the recurrent laryngeal nerve during surgeries where nerve integrity is at risk, such as thyroid and parathyroid surgeries.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy in nerve monitoring and a reduction in nerve injury rates during surgeries.
What complications have been reported?
Reported complications include technical challenges with electrode placement and signal interpretation, but no significant adverse events have been directly linked to the device.
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.