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Quadrasphere Microspheres
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 ?
510(k)
Number ?
K172372 ↗
Decision Date ?
September 6, 2017
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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.
FDA-Cleared Indications
- Embolization of blood vessels to promote occlusion or reduce blood flow.
- Use as an embolic agent in procedures performed under image guidance.
- Delivery of chemotherapeutic agents during drug-eluting bead embolization when used according to the device labeling.
Clinical Applications
- Transarterial chemoembolization of liver tumors with a loaded chemotherapeutic agent.
- Embolization of tumor-feeding arteries to reduce blood supply.
- Image-guided vascular embolization when intentional vessel occlusion is clinically indicated.
Reported off-label uses
- Embolization of hypervascular tumors outside the liver.
- Preoperative embolization to reduce blood loss during selected tumor surgeries.
- Treatment of selected bleeding or arteriovenous vascular lesions.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The beads are available in size ranges that expand after contact with fluid; the final diameter depends on hydration and handling.
- They are delivered through a compatible microcatheter under fluoroscopic or other image guidance. Catheter size, vessel diameter and blood-flow dynamics must be considered.
- When used for drug delivery, the selected chemotherapeutic agent, loading method and dose must follow the product labeling and treatment protocol.
- Avoid non-target embolization by confirming vascular anatomy and using careful angiographic monitoring; embolization of normal arteries can cause ischemia.
- MRI safety and artifact information should be confirmed in the current manufacturer labeling. The beads are not metallic, but the catheter, coils or other implanted materials used during the same procedure may affect MRI conditions.
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.