Bench-To-Clinic Development of Imageable Drug-Eluting Embolization Beads: Finding the Balance

Abstract

This review describes the historical development of an imageable spherical embolic agent and focuses on work performed in collaboration between Biocompatibles UK Ltd (a BTG International group company) and the NIH to demonstrate radiopaque bead utility and bring a commercial offering to market that meets a clinical need. Various chemistries have been investigated and multiple prototypes evaluated in search of an optimized product with the right balance of handling and imaging properties. Herein, we describe the steps taken in the development of DC Bead LUMI™, the first commercially available radiopaque drug-eluting bead, ultimately leading to the first human experience of this novel embolic agent in the treatment of liver tumors.

Graphical abstract

Keywords::

• cone-beam computed tomography
• drug-eluting bead
• radiopacity
• radiopaque bead
• transarterial chemoembolization

Disclaimer

AL Lewis, SL Willis, MR Dreher, Y Tang and K Ashrafi are employees of Biocompatibles UK Ltd, the manufacturer of DC Bead LUMI™, the product that is the subject of this review. The NIH does not in any way endorse the use of DC Bead LUMI. NIH and Biocompatibles have a Co-operative Research And Development Agreement (CRADA).

Acknowledgements

W Pritchard, J Karanian, J Esparza-Trujillo, I Bakhutashvili, O Franco and D Woods assisted in performance of certain preclinical studies. A Beck assisted with early bead preparation and evaluations. A Radaelli and M van Der Bom assisted with image processing techniques for certain clinical cases. MM Havakuk and Q de Reuter assisted with discussion of concepts surrounding bead dosimetry. V Krishnasamy, C Garcia, V Anderson, M Cruz and J Peretti assisted with clinical trial administration.

Financial & competing interests disclosure

The corresponding author (AL Lewis) and some coauthors, (SL Willis, MR Dreher, Y Tang and K Ashrafi) are employees of Biocompatibles UK Ltd, the manufacturer of DC Bead LUMI™, the product that is the subject of this review. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.