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sime trufeel
Sime Health
Summary: The Sime Trufeel by Sime Health is a Class 1 medical device used in uterine fibroid embolization. It was FDA cleared via the 510k pathway in 1991. The device is supported by 10 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway
510K
Number
K913048 ↗
Decision Date
September 19, 1991
Product Code
LYY
Device Class
Class 1
Evidence
0 studies
The Sime Trufeel was cleared by the FDA through the 510k pathway on September 19, 1991. It is manufactured by Sime Health and classified as a Class 1 device under product code LYY.
What It Is
The Sime Trufeel is a medical device designed for use in uterine fibroid embolization procedures. It is intended to aid in the embolization process, which involves blocking blood flow to fibroids in the uterus.
Clinical Applications
The device is commonly used in clinical settings for patients undergoing uterine fibroid embolization. This procedure is typically indicated for women experiencing symptoms from uterine fibroids, such as heavy menstrual bleeding or pelvic pain.
Evidence Summary
The available literature includes 10 studies, though the specific types and outcomes of these studies are not detailed in the provided evidence. The studies span recent years, with the latest being published in 2023.
Reported Outcomes
Published studies report limited specific outcomes related to the use of the Sime Trufeel device in uterine fibroid embolization. The provided evidence does not detail efficacy findings or patient outcomes.
Safety Profile
Reported complications include limited safety data, as the provided evidence does not specify adverse events or complications associated with the device. Further research is needed to establish a comprehensive safety profile.
Evidence Limitations
The evidence provided lacks detailed information on study outcomes and safety data. There is a need for more comprehensive research to better understand the efficacy and safety of the Sime Trufeel in clinical practice.
Frequently Asked Questions
What are the clinical indications for Sime Trufeel?
The Sime Trufeel is indicated for use in uterine fibroid embolization procedures.
What outcomes have been reported in clinical studies?
The provided evidence does not specify detailed outcomes from clinical studies involving the Sime Trufeel.
What complications have been reported?
Safety data from the provided evidence is limited, with no specific complications detailed.
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.