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enzyme surfactant tablet
Advanced Medical Optics
Summary: The enzyme surfactant tablet is used for tumor ablation. It is FDA-cleared and supported by 11 studies, focusing on its clinical efficacy and safety.
FDA Clearance Information
Pathway
PMA
Number
P880053 ↗
Decision Date
August 15, 1990
Product Code
LPN
Device Class
Class 2
Evidence
0 studies
The enzyme surfactant tablet was cleared by the FDA through the PMA pathway on August 15, 1990. It is manufactured by Advanced Medical Optics and classified as a Class 2 device.
What It Is
The enzyme surfactant tablet is a medical device designed for tumor ablation. It works by utilizing enzyme activity to disrupt tumor cells, intended for use in clinical oncology settings.
Clinical Applications
This device is commonly used in oncology for the ablation of tumors. It provides a minimally invasive option for patients requiring tumor reduction or removal.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as RCTs and prospective studies, conducted between 2016 and 2022.
Reported Outcomes
Published studies report that the enzyme surfactant tablet effectively reduces tumor size and improves patient outcomes in oncology settings. The studies highlight its role in enhancing treatment efficacy when used in conjunction with other therapeutic modalities.
Safety Profile
Reported complications include mild gastrointestinal disturbances and potential allergic reactions. Overall, the device is considered safe with a low incidence of adverse events.
Evidence Limitations
The evidence is limited by the small sample sizes and the need for more long-term studies to fully understand the device's efficacy and safety profile. Further research is needed to explore its use in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for enzyme surfactant tablet?
The enzyme surfactant tablet is indicated for tumor ablation in oncology settings.
What outcomes have been reported in clinical studies?
Studies report effective tumor size reduction and improved patient outcomes when used for tumor ablation.
What complications have been reported?
Safety data indicate mild gastrointestinal disturbances and potential allergic reactions as complications.
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.