{"entity":{"id":"embolic-microspheres","kind":"technology","name":"Embolic microspheres and hydrogel for tumour embolisation (Embosphere, Bead Block, HydroPearl, Embozene, Easi-Vue, Embrace)","aka":["Bland embolisation","Bland microspheres","Embolic beads","Embosphere","Bead Block","HydroPearl","Embozene","Easi-Vue","Radiopaque microspheres","EmboCept S","Degradable starch microspheres","Embrace hydrogel"],"tldr":"Tiny plastic or gel beads injected through a catheter into the artery feeding a tumour, to block its blood supply. Without a drug they are called bland embolisation; the same beads can carry chemotherapy in some countries.","summary":"In the United States embolic microspheres are cleared as vascular embolisation devices. Biosphere Medical's Embosphere (K250971, 16 May 2025, code KRD) is indicated for \"Hypervascular tumors, including symptomatic uterine fibroids\" and prostate artery embolisation; Biocompatibles' Bead Block (K203276, 20 April 2021) and MicroVention's HydroPearl (K192684, 22 January 2020) are listed under code NOY, which the FDA names for benign prostatic hyperplasia, with indications covering \"hypervascular tumors, including uterine fibroids\". Varian's Embozene Color-Advanced (K242608, 17 January 2025) names \"hepatoma\" among hypervascular tumours. ABK Biomedical's Easi-Vue (K234123, 13 February 2024) is radiopaque, so the beads themselves show on X-ray. Instylla's Embrace hydrogel embolic system, a liquid that sets in the vessel, was approved by PMA on 5 August 2025 (P250003, code QVG, class III). Magle PharmaCept lists EmboCept S degradable starch microspheres among its products; no US clearance was found for them.","status":"standard-of-care","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K250971: Embosphere microspheres (16 May 2025)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250971"},{"label":"FDA 510(k) K203276: Bead Block (20 April 2021)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203276"},{"label":"FDA 510(k) K192684: HydroPearl microspheres (22 January 2020)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192684"},{"label":"FDA 510(k) K242608: Embozene Color-Advanced microspheres (17 January 2025)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242608"},{"label":"FDA 510(k) K234123: Easi-Vue embolic microspheres (13 February 2024)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234123"},{"label":"FDA PMA P250003: Embrace hydrogel embolic system (5 August 2025)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250003"},{"label":"FDA product code NOY: embolic agents for benign prostatic hyperplasia","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NOY"},{"label":"Magle PharmaCept: products (EmboCept S)","url":"https://maglepharmacept.com/"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["hcc"],"sections":["surgery","devices"],"technologies":["tace","drug-eluting-beads","tace-delivery-microcatheters","radioembolisation-tare"],"targets":[],"drugs":[],"companies":["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":"Calibrated spheres or an in-situ setting hydrogel are injected through a microcatheter into the tumour's feeding arteries, lodging at a size-dependent depth and stopping flow so the tumour becomes ischaemic.","strengths":["Calibrated sizes reach a predictable vessel depth","Radiopaque beads can be seen during and after the procedure"],"limitations":["Non-target embolisation of normal organs","Post-embolisation pain, fever and nausea","American clearances are general, not specific to a cancer"],"since":2017},"route":"/technologies/embolic-microspheres/","neighbours":{"cancer":[{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"drug-eluting-beads","kind":"technology","name":"Drug-eluting beads for chemoembolisation (DC Bead, LC Bead, HepaSphere, ONCOZENE, CalliSpheres, LifePearl)","route":"/technologies/drug-eluting-beads/"},{"id":"tace-delivery-microcatheters","kind":"technology","name":"Microcatheters for tumour embolisation (balloon-occlusion and pressure-enabled delivery)","route":"/technologies/tace-delivery-microcatheters/"},{"id":"radioembolisation-tare","kind":"technology","name":"Radioembolisation (TARE / SIRT, yttrium-90)","route":"/technologies/radioembolisation-tare/"},{"id":"tace","kind":"technology","name":"Transarterial chemoembolisation (TACE)","route":"/technologies/tace/"}],"company":[{"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/"}]}}