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quadrasphere microspheres
Biosphere Medical
Summary: Quadrasphere microspheres are used for embolization in drug-eluting bead therapy, primarily for liver cancer. Key evidence highlights their use with chemotherapeutics like doxorubicin and irinotecan.
FDA Clearance Information
Pathway
510K
Number
K153102 ↗
Decision Date
November 23, 2015
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
Quadrasphere microspheres were cleared by the FDA via the 510(k) pathway on November 23, 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 used in embolization procedures. They are designed to deliver chemotherapeutic agents directly to tumors, particularly in the liver.
Clinical Applications
Commonly used in transarterial chemoembolization (TACE) for hepatocellular carcinoma, Quadrasphere microspheres facilitate targeted drug delivery, reducing systemic exposure and enhancing local drug concentration.
Evidence Summary
The literature includes five studies, ranging from 2010 to 2018, examining the pharmacokinetics, safety, and efficacy of Quadrasphere microspheres loaded with various chemotherapeutics. Study types include prospective and retrospective analyses.
Reported Outcomes
Published studies report that Quadrasphere microspheres effectively deliver chemotherapeutics like doxorubicin and irinotecan, achieving significant intratumoral drug concentrations. They have demonstrated efficacy in reducing tumor size in animal models and improving outcomes in hepatocellular carcinoma patients.
Safety Profile
Reported complications include typical embolization-related adverse events such as post-embolization syndrome. No significant systemic toxicity was observed in the studies, indicating a favorable safety profile.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to explore the full range of clinical applications and to confirm findings in larger, more diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Quadrasphere microspheres?
Quadrasphere microspheres are indicated for use in embolization procedures, particularly in the treatment of hepatocellular carcinoma through transarterial chemoembolization.
What outcomes have been reported in clinical studies?
Studies have reported effective drug delivery and tumor size reduction, with significant intratumoral concentrations of chemotherapeutics like doxorubicin and irinotecan.
What complications have been reported?
Safety data indicate typical embolization-related complications such as post-embolization syndrome, with no significant systemic toxicity observed.
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.