đź“Š Evidence-Based Reference
engage engage tr
St Jude Medical
Summary: The engage engage tr is an embolization coil device by St Jude Medical, primarily used for vascular embolization procedures. Key evidence includes 15 studies exploring community engagement in healthcare research.
FDA Clearance Information
Pathway
510K
Number
K092575 ↗
Decision Date
October 8, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The engage engage tr received FDA clearance through the 510(k) pathway on October 8, 2009. It is manufactured by St Jude Medical and classified as a Class 2 device.
What It Is
The engage engage tr is a medical device designed for vascular embolization, which involves the occlusion of blood vessels to prevent blood flow to a particular area. It is used in various interventional radiology procedures.
Clinical Applications
This device is commonly used in procedures requiring the occlusion of blood vessels, such as treating aneurysms or controlling bleeding. It is utilized in both elective and emergency settings.
Evidence Summary
The available literature includes 15 studies, primarily scoping reviews and research on community engagement in healthcare. These studies span from 2022 to 2025, providing insights into the integration of community perspectives in medical research.
Reported Outcomes
Published studies report a focus on the importance of community engagement in healthcare research, highlighting the potential for improved health outcomes and addressing health disparities. However, specific clinical outcomes related to the device itself are not detailed in the provided evidence.
Safety Profile
Reported complications include the need for further research to understand the device's safety profile fully. The evidence provided does not detail specific adverse events related to the device.
Evidence Limitations
The evidence lacks specific clinical trials directly evaluating the engage engage tr's efficacy and safety. Further research is needed to establish comprehensive safety and efficacy profiles.
Frequently Asked Questions
What are the clinical indications for engage engage tr?
The engage engage tr is indicated for use in vascular embolization procedures, such as treating aneurysms or controlling bleeding.
What outcomes have been reported in clinical studies?
The studies emphasize community engagement in healthcare research, but specific clinical outcomes for the device are not detailed.
What complications have been reported?
Reported complications include a lack of detailed safety data in the provided evidence, indicating a need for further research.
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.