FAQ'S

  1. What are the differences between LC Bead LUMI and LC Bead®?
  2. What has the feedback from KOLs been regarding LC Bead LUMI?
  3. Is it required to deliver LC Bead LUMI with contrast agent? Are specific contrast agents required?
  4. Which catheters should be used for optimal administration of LC Bead LUMI?
  5. What makes LC Bead LUMI radiopaque?
  6. How long does the radiopacity of LC Bead LUMI last?
  7. Under which imaging modalities can LC Bead LUMI be seen?
  8. a) How is LC Bead LUMI visualized after administration?b) What should I expect in post-procedural follow up imaging?
  9. What literature regarding LC Bead LUMI is available?
  10. What safety data is available on the use of LC Bead LUMI?


 

PRODUCT DETAILS, INDICATION, BENEFITS, AND POSITIONING


1. ​What are the differences between LC Bead LUMI and LC Bead®?

Attribute LC Bead LUMI LC Bead®
Radiopacity Developed from LC Bead® chemistry with a covalently bonded iodine to offer long term radiopacity. Proven chemistry; Uses blue dye; Not radiopaque
Color Pale golden color Blue
Calibration Precisely calibrated tp labelled sizing
Density Density = 1.30; Iodine content makes
LC Bead LUMI a little denser than LC Bead®
Density = 1.03; Less dense than LC Bead LUMI
Suspention Due to LC Bead LUMI being denser, it should be delivered in pure contrast to ensure a good suspension. Contrast can be diluted which will not impact suspension
Distal Penetration In-vitro testing of LC Bead LUMI™ indicates that the distal penetration is equivalent to equivalent sizes of LC Bead®
Sizes Available 40-90 µm
70-150 µm
100-300 µm
 
70-150 µm (LC BeadM1)
100-300 µm
300-500 µm
500-700 µm
 
Indication Both LC Bead LUMI and LC Bead® have been cleared by the FDA for the treatment of hypervascular tumors and arteriovenous malformations (AVMs).
Storage & Shelf Life Unopened: 24 month shelf life if stored at room temperature. Unopened: 48 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
Packaging containing vials with colored stoppers. Each vial contains 1ml or 2ml of beads.
Ordering Ordering processes will be the same for both products once LC Bead LUMI™ is commercially available. Please register for updates at LCBeadLUMI.com for updates.
Reimbursement Reimbursement codes will be the same for both products
 

2. What has the feedback from KOLs been regarding LC Bead LUMI?

BTG and many of the interventional radiologists we have spoken to are very excited by the opportunities offered by being able to actually visualize rather than infer the location of the beads during embolization therapy and at follow-up. It is believed that this will offer a new level of precision and control and allow for more real- time adjustments to optimize patient treatment.

3. Is it required to deliver LC Bead LUMI with contrast agent? Are specific contrast agents required?

LC 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 LC 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. LC Bead LUMI is visible on X-ray as the beads accumulate in the vessel and the contrast clears.

4. Which catheters should be used for optimal administration of LC Bead LUMI?

Once prepared, LC Bead LUMI™ has been tested and shown to be successfully delivered using the combinations of microsphere size, contrast medium and microcatheters shown in Table 2 in the IFU (copy provided below). A catheter with an internal diameter of ≥ 2.0 Fr (0.019 in/0.483 mm) is recommended for the 40-90um and 70-150um. A catheter with an internal diameter of ≥ 2.4 Fr (0.022 in/0.54 mm) may be preferred for 70-150um and 100-300um. Please note, following early stage experience, the recommendation is for new centers to treat using larger catheters (2.7/2.8 Fr) in initial patients to gain experience and confidence administrating, before using smaller catheters, if required.

Recommended Catheters and Contrast Agents for application with LC Bead LUMI:
Once prepared. LC Bead LUMI has been tested and shown to be successfully delivered using the combinations of microspheres size, contrast medium and microcatheters shown in Table 2.
Product Size Range of LC Bead LUMI Recommended Catheter (internal diameter) Recommended Contrast Agents
40-90µm
(40-100µm)*
≥ 2.0 Fr
(0.483mm/
0.019in)
Omnipaque 350 (Iohexol )
Iomeron 400 (Iomeprol)
Optiray 350 (Ioversol)
Oxilan 350 (Ioxilan)
Isovue 370 (Iopamidol)
Ultravist 370 (Iopromide)
70-150µm
(70-170µm)*
≥ 2.0 Fr
(0.483mm/
0.019in)
100-300µm
(70-340µm)*
≥ 2.4 Fr
(0.022mm/
0.54mm)
300-500µm
(250-550µm)*
≥ 4.0 Fr
(0.041in/
1.03mm)
Notes:
  • Other contrast agents have not been tested in conjuctions with LC Bead LUMI
  • Optiray 350. Oxilan 350. Isovue 370 have not been tested for the 300-500µm size range
  • Isovue 300 (Iopamidol) has been tested and is not recommended for use due the inadequate suspension times. Contrast agents of a similar or lower viscosity at 20C should not be used with LC Bead LUMI
  • *Potential bead size range based on manufacturers specification


RADIOPACITY AND VISUALIZATION

5. What makes LC Bead LUMI radiopaque?

LC Bead LUMI has been developed from the proven core chemistry used in LC Bead® with the blue dye replaced by a covalently bonded iodine to offer radiopacity.

6. How long does the radiopacity of LC Bead LUMI last?
The radiopacity is integral to the bead and will not degrade, so LC Bead LUMI will be visible on imaging at long-term follow-up.

7. Under which imaging modalities can LC Bead LUMI be seen?

Imaging modalities with which LC Bead LUMI are visible include Computed Tomography (CT), Cone Beam CT and fluoroscopy and x-ray ‘single’ or ‘snap’ shot. LC Bead LUMI is not visible with Magnetic Resonance Imaging (MRI). Imaging protocols that visualize soluble iodinated contrast medium are suitable for LC Bead LUMI. There is no need to recalibrate the equipment, although over time imaging manufacturers may issue guidelines or protocols to optimize visualization during LUMI-embolization procedures. Cone Beam CT is optimal, but not required.


8.a. How is LC Bead LUMI visualized after administration?

LC 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.

8.b. What should I expect in post-procedural follow up imaging?
LC Bead LUMI is easily visualized with CT. Early experience images from various different tumor types, show discrete embolized vessels where LC 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 LC Bead LUMI from contrast enhancement. 

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

PUBLICATIONS AND SUPPORTING DATA

9. What literature regarding LC Bead LUMI is available?

Duran 2015, Theranostics. 2016; 6(1):28-39
“A Novel Inherently Radiopaque Bead for Transarterial Embolization to Treat Liver Cancer – A Pre-clinical Study“

10. What safety data is available on the use of LC Bead LUMI?

LC Bead LUMI has been cleared by the FDA based on substantial equivalence to LC Bead®. Furthermore, ISO studies and preclinical 90 day hepatic swine safety studies have been conducted with LC Bead LUMI The results of those studies showed:

  • No systemic toxicity following implantation
  • No chronic inflammatory response observed
  • Macroscopic and microscopic changes limited to expected findings associated with occlusion of the liver’s arteries and healing response
  • Microscopic changes are typical for foreign body tissue response
  • No injury nor inflammatory response observed after 91 days