DC Bead LUMI™

Radiopaque Microsphere

DC Bead LUMI™ Vials
DC Bead LUMI™ Vials

DC Bead LUMI is the world’s first microsphere offering inherent, long-term radiopacity combined with the trusted performance of DC Bead

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Product Description

DC Bead LUMI™ — See More. Treat Smarter

VISION

With DC Bead LUMI™, you are empowered to see the bead during and after treatment.

During LUMI embolization — see precisely where DC Bead LUMI™ need to be delivered1.

LC Bead LUMI: Beginning of Injection
ACC: Beginning of Injection
LC Bead LUMI: Middle of Injection
ACC: Middle of Injection
LC Bead LUMI: End of Injection
ACC: End of Injection

Fluoroscopy Single shot; images courtesy NIH with permission*.

 

After LUMI embolization — with lasting radiopacity, DC Bead LUMI™ continues to be visible in follow-up scans1

LC Bead LUMI: NET; 48h FU; MDCT Coronal Plane
NET; 48h FU; MDCT Coronal Plane
LC Bead LUMI: HCC; 48h FU; MDCT Axial plane
HCC; 48h FU; MDCT Axial plane
LC Bead LUMI: ACC; 4 weeks FU; CBCT MIP Axail plane
ACC; 4 weeks FU; CBCT MIP Axail plane

ACC: adenoid cystic carcinoma; CBCT MIP: Cone-beam computed tomography maximum intensity projection; DSA: digital subtraction angiography; HCC: hepatocellular carcinoma; MDCT: multidetector computed tomography; NET: neuroendocrine tumor. Images courtesy of NIH with permission*.


DC Bead LUMI™ offers you a new level of control with real-time feedback both during and after embolisation.

 

PRECISION

DC Bead LUMI™ is designed to offer a more precise and controlled procedure than current techniques.

LC Bead LUMI: Shadowing artifact helps highlight treated regions.
Shadowing artefact helps highlight treated regions.
LC Bead LUMI: Vessels filled with beads clearly visible downstream of catheter placement
Vessels filled with beads clearly visable downstream of catheter placement.

CBCT MIP: Cone-beam computed tomography maximum intensity projection; DSA: digital subtraction angiography; HCC: hepatocellular carcinoma. Images courtesy of NIH with permission*.

DC Bead LUMI™ enables real-time adjustment during the whole procedure1.

 

ASSURANCE

DC Bead LUMI™ offers the best opportunity to individualize your patients’ treatment.

DC Bead LUMI™ offers the precision and control you need to:

Modify the procedure in real time1.
LC Bead LUMI: Shadowing artifact helps highlight treated regions.
Shadowing artefact helps highlight treated regions.
Evaluate the completeness of treatment1.
LC Bead LUMI: Embolized vessel clearly seen in red.
Embolized vessels clearly seen in red.
Inform decisions of future patient management1.
LC Bead LUMI: Showing area under treatment.
Showing area of under treatment.

CBCT MIP: Cone-beam computed tomography maximum intensity projection; DSA: digital subtraction angiography; HCC: hepatocellular carcinoma; MDCT: multidetector computed tomography; NET: neuroendocrine tumor. Images courtesy of NIH with permission*.

 

Product Specifications and Sizes

DC Bead LUMI™ are precisely calibrated, radiopaque, biocompatible, nonresorbable hydrogel beads. The beads are produced from polyvinyl alcohol and contain a covalently bound radiopaque moiety.

DC Bead LUMI™ are manufactured to be inherently radiopaque and visible under imaging (Computed Tomography [CT], Cone Beam Computed Tomography [CBCT] and Fluoroscopy). DC Bead LUMI™ are available in two size ranges:

Size Label Color
70-150µm Black

Presentation

  • DC Bead LUMI™ are offered in a prefilled 10ml glass vial, stopper sealed by an aluminum cap with a color-coded lid.
  • Each vial contains approximately 2ml of product in sterile phosphate buffered saline. The total volume of DC Bead LUMI™ and sterile physiological saline is approximately 8ml. 
  • Each package contains a sterile 20mm ViaLok™ Vented Vial Access Device for removal of DC Bead LUMI™ from the vial. 
  • Each vial of DC Bead LUMI™ is intended for single patient use only. Do not re-sterilize. Discard any unused material.

 

Attribute DC Bead LUMI
Radiopacity Developed from DC Bead chemistry with a covalently bonded iodine to offer long term radiopacity.
Color Pale golden color
Density Density - 1.30; Iodine content makes DC Bead LUMI a little denser than DC Bead
Suspention Due to DC Bead LUMI being denser, it shoudl be delivered in pure contrast to endure a good suspension.
Distal Penetration In-vitro testing of DC Bead LUMI indicates that the distal penetration is equivalen to sizes of DC Bead.
Storage & Shelf Life

Unopened: 24 month shelf life if stored at room temperature.

Opened: Once opened, should be used within 24 hours if refrigerated or 4 hours if at room temperature.

Packaging New packaging containing vials with colored stoppers, transfer device. Each vial contains 2ml of beads

Contrast Agents

DC Bead LUMI must be suspended in soluble iodinated contrast (a minimum of 20ml per vial) to achieve effective delivery through microcatheters and to aid visualization during administration. Only pure contrast (i.e. undiluted) should be used. The DC Bead LUMI IFU recommends using contrast agents Omnipaque 350 (Iohexol 350) and Iomeron 400 (Iomeprol 400). Based on post-approval early experience, please note that Visipaque provides an even better (long and stable) suspension. DC Bead LUMI is visible on X-ray as the beads accumulate in the vessel and the contrast clears.

Recommended Catheters and Contrast Agents for application with DC Bead LUMI

Once prepared, DC Bead LUMI has been tested and shown to be successfully delivered using the combinations of microspheres size, contrast medium and microcatheters shown in the table below.
DC Bead LUMI Recommended Catheter
(Internal Diameter)
70-150μm
≥2.0Fr
(0.483mm/0.019in)
Recommended Contrast Agents: Omnipaque 350 (lohexol), Iomeron 400 (Iomeprol), Optiray 350 (Ioversol), Oxilan 350 (Ioxilan), Isovue 370 (Iopamidol), Ultravist 350 (Iopromide).
  • Other contrast agents have not been tested in conjunction with DC Bead LUMI.
  • Optiray 350, Oxilan 350, and Isovue 370 have not been tested for the 300-500μmm size range.
  • Isovue 300 (Iopamidol) has been tested and is not recommended for use due to the inadequate suspension times. Contrast agents of a similar or lower viscosity at 20° C should not be used with DC Bead LUMI.

 

Radiopacity and Visualization

DC Bead LUMI is radiopaque from the proven core chemistry used in DC Bead with the blue dye replaced by a covalently bonded iodine to offer radiopacity. The radiopacity is integral to the bead and will not degrade, so DC Bead LUMI will be visible on imaging at long-term follow-up.

DC Bead LUMI is visible under x-ray imaging as they accumulate in the embolized vessels. It can be directly visualized as the delivery contrast agent washes out. Best visualization is achieved after administration using X-ray single shot technique (also referred to as X-ray snap shot). Cone beam CT (CBCT) can also be used to visualize the beads accumulated in the vessels with multi-planar reconstructions providing 3D spatial bead location and vessel connectivity.

DC Bead LUMI is easily visualized with CT. Early experience images from various different tumor types, show discrete embolized vessels where DC Bead LUMI is present with no significant streak artefacts nor masking of adjacent tissue unlike commonly seen following lipiodol containing treatments. If contrast enhanced CT images are desired, obtaining a non-contrast image may be helpful to discriminate DC Bead LUMI from contrast enhancement.

The radiopacity of DC Bead LUMI does not degrade over time, so the beads will continue to be visible at follow up.

Drug Loading and Elution

  • Approved for loading with doxorubicin and irinotecan.
  • In-vitro testing confirms that the controlled and sustained elution profiles of drug from DC Bead LUMI™are comparable to those achieved with DC Bead™
  • Elution of doxorubicin and irinotecan falls within the same window as DC Bead™1
  • Under the same conditions, both DC Bead LUMITM  and DC BeadTM achieve complete elution of doxorubicin and irinotecan 1,2 
  • DC Bead LUMITM do not reduce in diameter when loaded with drug.
1 Swaine TS et al. Poster presentation APS meeting, Nottingham, UK. September 2015.
2 Data on file (FAR-ES-0121) at Biocompatibles UK
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France. 2020 Copyright © Boston Scientific Corporation or its affiliates. All rights reserved. 93-204   
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