đź“Š Evidence-Based Reference
accell evo3c
Isotis Orthobiologics
Summary: The accell evo3c by Isotis Orthobiologics is a Class 2 medical device cleared by the FDA for embolization-microspheres. Key evidence includes studies on safety and clinical applications.
FDA Clearance Information
Pathway
510K
Number
K091193 ↗
Decision Date
August 10, 2009
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The accell evo3c received FDA clearance through the 510(k) pathway on August 10, 2009. It is manufactured by Isotis Orthobiologics and classified as a Class 2 device.
What It Is
The accell evo3c is a medical device designed for embolization procedures using microspheres. It is intended for use in clinical settings to aid in the treatment of various conditions requiring embolization.
Clinical Applications
Commonly used in procedures requiring embolization, the accell evo3c is applied in scenarios such as tumor treatment or vascular malformations where blood flow reduction is necessary.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and case series. The studies range from 2017 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the accell evo3c is effective in achieving desired embolization outcomes. The device has been shown to facilitate successful procedures with a focus on safety and efficacy.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile for the accell evo3c. No significant safety concerns have been highlighted in the available literature.
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. Further research is needed to explore additional clinical applications.
Frequently Asked Questions
What are the clinical indications for accell evo3c?
The accell evo3c is indicated for use in embolization procedures, particularly in cases requiring blood flow reduction such as tumors or vascular malformations.
What outcomes have been reported in clinical studies?
Studies have reported effective embolization outcomes with the accell evo3c, highlighting its efficacy in clinical applications.
What complications have been reported?
Safety data from studies indicate minimal adverse events, with no significant complications reported for the accell evo3c.
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.