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Quadrasphere Microspheres
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 ?
510(k)
Number ?
K153102 ↗
Decision Date ?
November 23, 2015
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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.
FDA-Cleared Indications
- Embolization of blood vessels to reduce or stop blood flow.
- Use as an embolic agent in procedures requiring vascular occlusion, as described by the product labeling.
- Use for delivery of chemotherapeutic drugs during embolization when consistent with the labeled device and procedure.
Clinical Applications
- Transarterial chemoembolization for selected liver tumors, including hepatocellular carcinoma, when the treatment plan and drug use follow applicable labeling.
- Catheter-directed embolization of appropriately selected vessels using image guidance.
- Temporary or intended vascular occlusion in procedures for which an injectable embolic microsphere is indicated.
Reported off-label uses
- Embolization of hypervascular tumors outside the liver.
- Uterine artery embolization for symptomatic uterine fibroids.
- Embolization of selected bleeding vessels or arteriovenous malformations.
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, 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.
Practical Considerations
- Microspheres are supplied in different size ranges; the selected size depends on the target vessel, flow rate, vascular anatomy and desired level of embolization.
- They are delivered through a compatible catheter under fluoroscopic or other appropriate imaging guidance. The suspension must be prepared and administered according to the current instructions for use.
- The operator must consider catheter inner diameter, bead concentration, suspension fluid and the risk of reflux or non-target embolization.
- Contraindications and precautions include uncorrectable coagulopathy, severe infection in the treatment area, nonvisualized or unsafe target vessels, and allergies or other restrictions specified in the labeling.
- MRI safety depends on the final device composition and the current manufacturer labeling. The product's MRI conditions should be checked before scanning; embolized tissue and any accompanying devices may also affect MRI planning.
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.