📊 Evidence-Based Reference

HepaSphere Microspheres

Summary: HepaSphere Microspheres are embolization devices used primarily for transarterial chemoembolization. Key evidence highlights their use in treating liver metastases with irinotecan-loaded microspheres.

FDA Clearance Information

Pathway ? 510(k)

Number ? K052742 ↗

Decision Date ? November 7, 2006

Product Code ? KRD Device, Vascular, For Promoting Embolization

Device Class ? Class 2

Evidence ? 8 studies

HepaSphere Microspheres received FDA clearance through the 510(k) pathway on November 7, 2006. Manufactured by Biosphere Medical, they are classified as Class 2 devices.

What It Is

HepaSphere Microspheres are embolic agents designed for controlled embolization in hypervascular tumors. They are used to deliver chemotherapeutic agents directly to the tumor site, minimizing systemic exposure.

FDA-Cleared Indications

Embolization of blood vessels supplying hypervascular tumors.
Embolization procedures in which controlled occlusion of selected blood vessels is clinically indicated.

Clinical Applications

Embolization of arteries supplying hypervascular tumors.
Transarterial chemoembolization when the microspheres are prepared with a compatible chemotherapeutic agent according to product labeling.
Selective or superselective embolization performed through a catheter under imaging guidance.

Reported off-label uses

Embolization for symptomatic benign prostatic hyperplasia.
Embolization of selected hypervascular tumors or tumor-related bleeding outside the specific labeled indication.

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 14 studies, comprising prospective and retrospective analyses, spanning from 2015 to 2023. These studies evaluate safety, efficacy, and clinical outcomes of HepaSphere Microspheres.

Reported Outcomes

Published studies report that HepaSphere Microspheres are effective in delivering chemotherapeutic agents directly to tumors, with significant tumor response in liver metastases. They have shown comparable efficacy to other embolic agents in preclinical models.

Safety Profile

Reported complications include post-embolization syndrome, characterized by pain and fever, which are common in embolization procedures. No severe adverse events directly attributed to the device were noted in the studies.

Evidence Limitations

The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish long-term safety and efficacy, particularly in diverse patient populations.

Practical Considerations

Microspheres are supplied in different size ranges and expand after contact with fluid; the selected size depends on the target vessel, blood flow and desired level of embolization.
They are delivered through a compatible microcatheter after suspension in an appropriate liquid. Careful mixing and continuous agitation help maintain an even suspension.
Embolization should be performed with angiographic imaging by clinicians trained in catheter-directed vascular procedures.
Do not inject the microspheres into unintended vessels or through a catheter system that is not compatible with the product; non-target embolization can cause tissue ischemia.
MRI safety and artifact information should be confirmed in the current product labeling. The microspheres are not a substitute for evaluating contraindications to embolization, including significant uncorrectable coagulopathy or an inability to safely catheterize the target vessel.