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quadrasphere microspheres
Biosphere Medical
Summary: Quadrasphere microspheres are embolization devices used primarily for drug-eluting bead therapy. Key evidence highlights their use in chemoembolization for liver tumors, with studies examining safety and efficacy.
FDA Clearance Information
Pathway
510K
Number
K151187 ↗
Decision Date
July 27, 2015
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
Quadrasphere microspheres were cleared by the FDA via the 510(k) pathway on July 27, 2015. Manufactured by Biosphere Medical, they are classified as Class 2 devices.
What It Is
Quadrasphere microspheres are super absorbent polyvinyl alcohol-sodium acrylate copolymer beads designed for embolization procedures. They are intended for use in drug-eluting bead therapy, particularly in the treatment of liver tumors.
Clinical Applications
Commonly used in transarterial chemoembolization (TACE) for hepatocellular carcinoma, Quadrasphere microspheres are employed to deliver chemotherapeutic agents directly to liver tumors, minimizing systemic exposure.
Evidence Summary
The literature includes five studies, ranging from 2010 to 2018, encompassing various study designs such as RCTs and case series. These studies investigate the loading, elution, and clinical efficacy of Quadrasphere microspheres.
Reported Outcomes
Published studies report that Quadrasphere microspheres are effective in delivering chemotherapeutic agents like doxorubicin and irinotecan directly to liver tumors. They demonstrate favorable pharmacokinetics and intratumoral drug concentrations, contributing to their efficacy in tumor reduction.
Safety Profile
Reported complications include typical embolization-related adverse events, such as post-embolization syndrome. However, specific safety data from the studies provided is limited, necessitating further research for comprehensive safety profiling.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term outcome data. Further research is needed to establish comprehensive safety profiles and to explore the efficacy of Quadrasphere microspheres in broader clinical settings.
Frequently Asked Questions
What are the clinical indications for Quadrasphere microspheres?
Quadrasphere microspheres are indicated for use in embolization procedures, particularly in drug-eluting bead therapy for liver tumors such as hepatocellular carcinoma.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective delivery of chemotherapeutic agents to liver tumors, with favorable pharmacokinetics and intratumoral drug concentrations.
What complications have been reported?
Reported complications include typical embolization-related adverse events, such as post-embolization syndrome, though specific safety data is limited.
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.