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evs
Applied Medical Resources
Summary: The evs by Applied Medical Resources is a Class 2 device used in embolization procedures. Key evidence highlights its role in intercellular communication and potential therapeutic applications.
FDA Clearance Information
Pathway
510K
Number
K963886 ↗
Decision Date
April 24, 1997
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The evs device was cleared by the FDA through the 510(k) pathway on April 24, 1997. It is manufactured by Applied Medical Resources and classified as a Class 2 device.
What It Is
The evs device is designed for use in embolization procedures, primarily involving the delivery of embolization coils. It functions by facilitating intercellular communication through extracellular vesicles (EVs).
Clinical Applications
Commonly used in scenarios requiring embolization, the evs device is applied in procedures to occlude blood vessels, often in the treatment of aneurysms or other vascular abnormalities.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and case series, published between 2023 and 2024. These studies explore the therapeutic potential and diagnostic applications of EVs.
Reported Outcomes
Published studies report that EVs have shown potential in protecting against skin photodamage and enhancing targeted therapy. They also highlight the role of EVs in intercellular communication and disease diagnostics.
Safety Profile
Reported complications include potential immune system clearance of EVs during in vivo transport, which may limit their therapeutic efficacy. No other significant adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the relatively recent publication dates, indicating a need for further research to establish long-term efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for evs?
The evs device is indicated for use in embolization procedures, particularly involving the delivery of embolization coils.
What outcomes have been reported in clinical studies?
Studies have reported that EVs can protect against skin photodamage and enhance targeted therapy, with potential applications in disease diagnostics.
What complications have been reported?
Safety data indicates that EVs may be susceptible to immune system clearance during transport, potentially limiting therapeutic efficacy.
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.