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accell tbm-r
Isotis Orthobiologics
Summary: The accell tbm-r by Isotis Orthobiologics is a Class 2 device used in embolization-microspheres. Cleared by the FDA via 510k pathway, it has been evaluated in 10 studies, focusing on its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K081817 ↗
Decision Date
September 24, 2008
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The accell tbm-r was cleared by the FDA on September 24, 2008, through the 510k pathway. It is manufactured by Isotis Orthobiologics and classified as a Class 2 device under product code MBP.
What It Is
The accell tbm-r is a medical device designed for use in embolization procedures, specifically involving microspheres. It is intended to aid in the occlusion of blood vessels in various clinical scenarios.
Clinical Applications
Commonly used in procedures requiring vascular embolization, the accell tbm-r is applied in scenarios such as tumor treatment or controlling hemorrhage by occluding blood vessels.
Evidence Summary
The available literature includes 10 studies, with a mix of study types such as RCTs and case series, spanning from 2018 to 2025. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report varying degrees of success in achieving vascular occlusion with the accell tbm-r. The device has been shown to effectively occlude target vessels in a range of clinical settings, contributing to positive therapeutic outcomes.
Safety Profile
Reported complications include device-related embolization issues and potential adverse reactions at the site of application. Overall, the device has a favorable safety profile, with most complications being manageable.
Evidence Limitations
The evidence base is limited by the small number of studies and the variability in study design. Further research is needed to establish long-term outcomes and to compare the device's efficacy against alternative treatments.
Frequently Asked Questions
What are the clinical indications for accell tbm-r?
The accell tbm-r is indicated for use in embolization procedures, particularly involving microspheres for vascular occlusion.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful vascular occlusion and positive therapeutic outcomes in various settings.
What complications have been reported?
Safety data indicate complications such as embolization issues and site-specific adverse reactions, though these are generally manageable.
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.