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quadrasphere microspheres
Biosphere Medical
Summary: Quadrasphere microspheres are embolization devices used primarily in drug-eluting bead therapy for liver tumors. Key evidence highlights their use with chemotherapeutics like doxorubicin and irinotecan.
FDA Clearance Information
Pathway
510K
Number
K172372 ↗
Decision Date
September 6, 2017
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
Quadrasphere microspheres were cleared by the FDA through the 510(k) pathway on September 6, 2017. 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, reducing systemic exposure.
Clinical Applications
Commonly used in transarterial chemoembolization (TACE) for hepatocellular carcinoma, Quadrasphere microspheres are employed to deliver drugs like doxorubicin and irinotecan directly to liver tumors.
Evidence Summary
The literature includes five studies ranging from 2010 to 2018, comprising RCTs and other study designs. These studies explore the pharmacokinetics, safety, and efficacy of Quadrasphere microspheres in drug delivery.
Reported Outcomes
Published studies report that Quadrasphere microspheres effectively deliver chemotherapeutic agents like doxorubicin and irinotecan to liver tumors, achieving localized drug concentration and reducing systemic side effects.
Safety Profile
Reported complications include typical embolization-related adverse events such as post-embolization syndrome. No unique safety concerns specific to Quadrasphere microspheres were highlighted in the studies.
Evidence Limitations
The evidence is limited by small sample sizes and a focus on preclinical models. Further research is needed to establish long-term outcomes and comparative efficacy against other embolization devices.
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?
Studies report effective localized delivery of chemotherapeutics with reduced systemic exposure, particularly in the treatment of liver tumors.
What complications have been reported?
Safety data indicate typical embolization-related adverse events, with no unique complications specific to Quadrasphere microspheres.
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.