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Evs
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 ?
510(k)
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).
FDA-Cleared Indications
- Use in embolization procedures.
- Delivery of embolization coils or other embolic materials to occlude selected blood vessels.
Clinical Applications
- Catheter-based embolization of selected arteries or veins.
- Delivery of embolization coils for treatment of aneurysms or pseudoaneurysms.
- Embolization to control bleeding from a selected blood vessel.
- Embolization of abnormal vascular connections or malformations when clinically indicated.
Reported off-label uses
- Embolization of hypervascular tumors as part of multidisciplinary treatment.
- Preoperative devascularization of selected tumors or vascular lesions.
- Treatment of venous reflux or congestion in selected pelvic or gonadal vein disorders.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The provided FDA record does not specify device dimensions, coil sizes, catheter compatibility, or the exact embolic materials supported; these details should be verified in the device labeling.
- Embolization is performed with fluoroscopic or other imaging guidance through a catheter, commonly introduced through the femoral or radial artery, or a venous access site depending on the target.
- MRI safety, including whether the device is MR Safe, MR Conditional, or not evaluated for MRI, is not established by the information provided and must be confirmed in the labeling.
- Potential complications include non-target embolization, vessel injury, bleeding or hematoma at the access site, ischemia, infection, and incomplete or unintended vessel occlusion.
- Contraindications, anticoagulation management, and the choice of embolic material depend on the target vessel, blood flow, anatomy, and the specific product instructions for use.
Procedures that use this device
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.