{"entity":{"id":"drug-eluting-beads","kind":"technology","name":"Drug-eluting beads for chemoembolisation (DC Bead, LC Bead, HepaSphere, ONCOZENE, CalliSpheres, LifePearl)","aka":["DEB-TACE","Drug-eluting bead","Drug-loadable microspheres","DC Bead","LC Bead LUMI","DEBDOX","DEBIRI","HepaSphere","QuadraSphere","ONCOZENE","CalliSpheres","LifePearl","Tandem"],"tldr":"Beads that soak up a chemotherapy drug before they are injected into the liver's arteries, then block the tumour's blood supply and release the drug slowly inside it. In a randomised trial they did not beat the older oil-based method overall, though some groups of patients responded better.","summary":"In Europe Boston Scientific describes DC Bead as \"a loadable microsphere product primarily intended as an embolic agent for the local treatment of malignant hypervascularised tumour(s) in the liver\", loaded with doxorubicin for hepatocellular carcinoma (DEBDOX) or with irinotecan for colorectal liver metastases (DEBIRI). American clearances read here are for embolisation only: LC Bead LUMI (Biocompatibles, K162373, 16 December 2016), is intended \"for the embolization of hypervascular tumors and arteriovenous malformations\"; QuadraSphere (Biosphere Medical, K172372, 6 September 2017), \"hypervascularized tumors including hepatoma\"; Varian's ONCOZENE (K242794, 16 October 2024), \"hypervascular tumors including hepatoma\"; and Suzhou Hengrui Callisyn's CalliSpheres (K173871, 17 September 2018, code NAJ), \"hypervascular tumors, including uterine fibroids\".\n\nPRECISION V randomised 212 patients with hepatocellular carcinoma to doxorubicin-loaded DC Bead or conventional oil-based chemoembolisation. Complete response (27 against 22 per cent), objective response (52 against 44 per cent) and disease control (63 against 52 per cent) were higher with beads, but \"The hypothesis of superiority was not met\" (one-sided P = 0.11); patients with Child-Pugh B, performance status 1, bilobar or recurrent disease had significantly better objective response. In the laboratory, DC Bead, LifePearl, HepaSphere and Tandem all loaded more than 99 per cent of doxorubicin within an hour but released it at different rates.","status":"standard-of-care","asOf":"2026-11-04","links":[{"label":"Boston Scientific (Europe): DC Bead and DC Bead M1","url":"https://www.bostonscientific.com/en-EU/products/embolics/dc-bead.html"},{"label":"FDA 510(k) K162373: LC Bead LUMI (16 December 2016)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162373"},{"label":"FDA 510(k) K172372: QuadraSphere microspheres (6 September 2017)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172372"},{"label":"FDA 510(k) K242794: ONCOZENE microspheres (16 October 2024)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242794"},{"label":"FDA 510(k) K173871: CalliSpheres embolic microspheres (17 September 2018)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173871"},{"label":"Lammer et al., PRECISION V: doxorubicin-eluting beads against conventional TACE (Cardiovasc Intervent Radiol 2010)","url":"https://doi.org/10.1007/s00270-009-9711-7"},{"label":"In vitro comparison of four drug-eluting microspheres loaded with doxorubicin (J Vasc Interv Radiol 2016)","url":"https://doi.org/10.1016/j.jvir.2016.05.015"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["hcc","colorectal"],"sections":["surgery","chemotherapy","devices"],"technologies":["tace","embolic-microspheres","tace-delivery-microcatheters"],"targets":[],"drugs":["doxorubicin","irinotecan","ethiodized-oil"],"companies":["boston-scientific","varian"],"institutions":[],"pathways":[],"terms":["tace-term","liver-directed-therapy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, Europe PMC, maker pages)","editedOn":"2026-11-04"},"principle":"Ion-exchange hydrogel microspheres bind positively charged drugs such as doxorubicin or irinotecan; after embolisation they release the drug locally over days while occluding the tumour's arterial supply.","strengths":["Less drug reaches the rest of the body than with oil-based chemoembolisation","Standardised bead sizes and loading"],"limitations":["Not superior to conventional chemoembolisation overall in PRECISION V","Drug loading is a European, not an American, labelled use"],"since":2016},"route":"/technologies/drug-eluting-beads/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"},{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"embolic-microspheres","kind":"technology","name":"Embolic microspheres and hydrogel for tumour embolisation (Embosphere, Bead Block, HydroPearl, Embozene, Easi-Vue, Embrace)","route":"/technologies/embolic-microspheres/"},{"id":"tace-delivery-microcatheters","kind":"technology","name":"Microcatheters for tumour embolisation (balloon-occlusion and pressure-enabled delivery)","route":"/technologies/tace-delivery-microcatheters/"},{"id":"tace","kind":"technology","name":"Transarterial chemoembolisation (TACE)","route":"/technologies/tace/"}],"drug":[{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"ethiodized-oil","kind":"drug","name":"Ethiodized oil","route":"/drugs/ethiodized-oil/"},{"id":"irinotecan","kind":"drug","name":"Irinotecan (and liposomal irinotecan)","route":"/drugs/irinotecan/"}],"company":[{"id":"boston-scientific","kind":"company","name":"Boston Scientific","route":"/companies/boston-scientific/"},{"id":"varian","kind":"company","name":"Varian (Siemens Healthineers)","route":"/companies/varian/"}],"term":[{"id":"liver-directed-therapy","kind":"term","name":"Liver-directed therapy (TACE, TARE, HAI, ablation)","route":"/terms/liver-directed-therapy/"},{"id":"tace-term","kind":"term","name":"TACE (transarterial chemoembolisation)","route":"/terms/tace-term/"}]}}