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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 ?
510(k)
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.
FDA-Cleared Indications
- Embolization microspheres intended to occlude selected blood vessels.
- Use in vascular embolization procedures when temporary or permanent vessel occlusion is clinically indicated, according to the device labeling.
Clinical Applications
- Catheter-directed embolization of selected blood vessels.
- Vascular occlusion during procedures for which embolization is indicated.
- Embolization of tumor-feeding vessels when specifically covered by the device labeling and treatment plan.
- Control of bleeding by catheter-directed vascular embolization when indicated.
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.
Practical Considerations
- The appropriate microsphere size and delivery catheter depend on the target vessel, vascular anatomy, and intended degree of occlusion; clinicians should follow the product labeling.
- Embolization requires imaging guidance and careful confirmation of catheter position to reduce the risk of unintended delivery to non-target vessels.
- Contraindications and precautions may include non-target vascular anatomy, uncorrectable coagulopathy, severe vessel spasm, infection at the access site, or allergy to relevant materials or contrast agents.
- MRI safety, including whether the device is MR Safe, MR Conditional, or not evaluated, should be confirmed in the current manufacturer labeling. Embolization microspheres may remain in the body, but MRI conditions cannot be assumed from the device name alone.
- The device is delivered through a compatible catheter, usually through arterial access such as the common femoral or radial artery, depending on the treatment site.
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.