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hepasphere microspheres
Biosphere Medical
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 510K
Number K052742 ↗
Decision Date November 7, 2006
Product Code KRD
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.
Clinical Applications
Commonly used in transarterial chemoembolization (TACE) for liver metastases, HepaSphere Microspheres are also applied in treating hypervascular tumors and benign prostatic hyperplasia.
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.
Linked Studies (8)
PubMed • 2023
Prospective Series of Transarterial Chemoembolization of Metastatic Colorectal Cancer to the Liver with 30-60 μm Microspheres Loaded with Irinotecan.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2016
Transcatheter arterial embolization of hypervascular tumors with HepaSphere: prospective multicenter open label clinical trial of microspheres in Japan.
Japanese journal of radiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2016
Safety and efficacy compared between irinotecan-loaded microspheres HepaSphere and DC bead in a model of VX2 liver metastases in the rabbit.
Journal of vascular and interventional radiology : JVIR
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2015
Chemoembolization of hepatocellular carcinoma with HepaSphere 30-60 μm. Safety and efficacy study.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2010
[Embolization of high flow arteriovenous malformations with HepaSphere microspheres].
Zhonghua zheng xing wai ke za zhi = Zhonghua zhengxing waike zazhi = Chinese journal of plastic surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2009
Transarterial chemoembolization for hepatocellular carcinoma with drug-eluting microspheres: preliminary results from an Italian multicentre study.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source → ClinicalTrials.gov
HepaSphere Chemoembolization in Advanced HCC Patients: Safety & Efficacy Registry in China
View Source → ClinicalTrials.gov
HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer
View Source →Frequently Asked Questions
What are the clinical indications for HepaSphere Microspheres?
HepaSphere Microspheres are indicated for embolization in hypervascular tumors and for transarterial chemoembolization in liver metastases.
What outcomes have been reported in clinical studies?
Studies report effective tumor response and comparable efficacy to other embolic agents in liver metastases treatment.
What complications have been reported?
Reported complications include post-embolization syndrome, with no severe adverse events directly linked to the device.
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.