Embozene Tandem® Microspheres are indicated for the embolization of blood vessels supplying primary hypervascular tumors or metastases in the liver.
Embozene Tandem® microspheres are designed for drug loading and elution of a local, controlled, sustained drug dose after embolization. They are available in three highly calibrated microsphere sizes (40, 75 and 100 μm) in volumes of 2 and 3 ml of product, and presented in prefilled syringes. Each microsphere, meticulously crafted with ≥95% of the microspheres being within the specified size range (1), guarantees accurate targeting of the specific vasculature.
Embozene Tandem® microspheres redefine precision with sizes down to 40 μm, ensuring targeted delivery of cytostatic drugs to tumor-feeding arteries.
The smaller particle sizes (40 or 75 μm) contribute to better intratumoral distribution (4), allowing physicians precise control in delivering chemotherapy directly to tumor-feeding arteries, when performing selective TACE (Transarterial chemo
In an examination of liver explants in humans, it was found that just 42% of blocked vessels resided within the tumor when employing 100–300 μm DEBs (drug-eluting beads) (13). This underlines the importance of smaller and precisely calibrated DEBs, which allow a more distal embolization in the tumoral arterial network.
The 40 μm Embozene Tandem® beads allow deep and large volume implantation into the tumor. Histological examinations show the presence of doxorubicin-loaded beads within the interstitium of the tumor, the deepest level achievable (15).
DEB (white arrows), in large numbers, within the interstitium, with adjacent capillaries observed. (CD34 immunostaining of capillaries; original magnification, x20) (15)
Due to their tight and uniform size distributions, more microspheres occupy the same volume as compared with a wider size range. For example, a sphere with a diameter of 300 μm occupies 27-times the volume of one 100-μm sphere, thus enabling more 100-μm spheres to occupy the same volume as one 300-μm sphere (13).
Embozene Tandem® Microspheres excel in precise calibration, enabling the delivery of a greater number of small microspheres (≤100 μm) in the same volume. This advantage promotes deeper penetration, higher density, and more predictable coverage within the tumor, enhancing drug exposure and distribution for optimal therapeutic outcomes (13, 15, 16).
The distinctive solutions, featuring single unit syringes in 2 ml or 3 ml options, set a new standard for flexibility in microsphere counts, while distinguishing it as the sole 3 ml drug-eluting microsphere product on the market.
The ability to load Embozene Tandem® with various chemotherapeutic agents allows a personalized treatment strategy, addressing each patient's unique condition and characteristics.
Embozene Tandem® microspheres achieve over 99% doxorubicin loading within just 1 hour and 30 minutes for the loading of irinotecan, ensuring swift and dependable drug incorporation (13).
(a) entire duration and (b) reduced time range to illustrate the differences in loading (2).
Embozene Tandem® microspheres maintain their distinct shapes and remain separate and spherical, before and after loading with doxorubicin, ensuring stability and consistency (2).
Photomicrographs of doxorubicin-loaded LifePearl (a), DC Bead (b), Tandem (c), and HepaSphere (d) microspheres. Inset images in the lower left corners are photomicrographs of unloaded microspheres. (Scale bars: 200 µm.) (2)
The average diameters of LifePearl, DC Bead, and Tandem microspheres were reduced after loading by 24%, 20%, and 9%, respectively (2).
Diameter distribution histograms of doxorubicin-loaded DC Bead (blue), HepaSphere (orange), LifePearl (green), and Embozene Tandem® (red)
microspheres (2).
Designed to load up to 50 mg/ml of doxorubicin, Embozene Tandem® Microspheres set a new standard in the market, offering healthcare professionals the option to release more doxorubicin, if needed and tolerated by the patient, for improved tumor necrosis. As the exclusive provider of a 3 ml drug-eluting microsphere product, it empowers healthcare professionals to deliver up to 150 mg maximum dose per patient with unparalleled precision and efficacy.
Controlled and sustained drug release with the flexibility to deliver more doxorubicin (1, 17, 18)
The versatile drug loading possibilities of the Embozene Tandem® microspheres empower physicians to tailor the treatment by choosing and loading the beads with the most suitable chemotherapeutic agent and dose. This personalized approach addresses the unique needs of each patient for a more effective outcome.
The hydrogel matrix of Embozene Tandem® ensures efficient intratumoral concentrations and a sustained drug release, resulting in improved pharmacokinetic profiles (19). This translates to minimized systemic side effects, enhancing patient comfort and compliance throughout the treatment process and a smoother recovery process with reduced post-procedural discomfort, making it the ideal choice for advancing patient care (12, 13).
The Embozene Tandem® (Oncozene in US) microspheres offer a dual advantage by necessitating a significantly lower doxorubicin dose in comparison to alternative products, thus potentially minimizing drug-related adverse effects (20), while demonstrating comparable or superior short-term radiographic tumor response and survival rates, affirming its efficacy and safety. Furthermore, the lower doxorubicin doses suggest a potential cardioprotective benefit, particularly relevant for patients undergoing multiple TACE procedures (19).
Comparison of Progression-Free Survival and Overall Survival using Embozene Tandem® (19)
Embozene Tandem® microspheres exhibit prolonged time in suspension after loading with doxorubicin, facilitating smoother embolization procedures without frequent interruptions (2).
In comparison with alternative products, Embozene Tandem® microspheres exhibit delayed irinotecan elution, with approximately 70% elution at 6 hours. This offers a unique advantage for patients by minimizing systemic side effects throughout the treatment process and minimizing post-procedural discomfort, while resulting in equivalent treatment efficacy (13, 21-23).
Additionally, after loading with irinotecan, the average diameter was unchanged for Embozene Tandem® microspheres, while the average diameter of alternative products was reduced by 9% and 18% respectively (3).
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1 Data on file. Varian Medical Systems, Inc. 2020.
2 de Baere, T., Plotkin, S., Yu, R., Sutter, A., Wu, Y., & Cruise, G. M. (2016). An In Vitro Evaluation of Four Types of Drug-Eluting Microspheres Loaded with Doxorubicin. Journal of vascular and interventional radiology : JVIR, 27(9), 1425–1431. https://doi.org/10.1016/j.jvir.2016.05.015
3 Pereira, P. L., Plotkin, S., Yu, R., Sutter, A., Wu, Y., Sommer, C. M., & Cruise, G. M. (2016). An in-vitro evaluation of three types of drug-eluting microspheres loaded with irinotecan. Anti-cancer drugs, 27(9), 873–878. https://doi.org/10.1097/CAD.0000000000000408
4 Bonomo, G., Monfardini, L., Vigna, P.D., Orgera, G., Pedicini, V., & Orsi, F. (2009). Does Microparticle Size Affect Bland Embolization Outcomes of Local Treatment for Liver Malignancies.
5 Stampfl, S., Bellemann, N., Stampfl, U., Sommer, C. M., Thierjung, H., Lopez-Benitez, R., Radeleff, B., Berger, I., & Richter, G. M. (2009). Arterial distribution characteristics of Embozene particles and comparison with other spherical embolic agents in the porcine acute embolization model. Journal of vascular and interventional radiology : JVIR, 20(12), 1597–1607. https://doi.org/10.1016/j.jvir.2009.08.018
6 Yamakado, K., Miyayama, S., Hirota, S., Mizunuma, K., Nakamura, K., Inaba, Y., Maeda, A., Matsuo, K., Nishida, N., Aramaki, T., Anai, H., Koura, S., Oikawa, S., Watanabe, K., Yasumoto, T., Furuichi, K., & Yamaguchi, M. (2012). Hepatic arterial embolization for unresectable hepatocellular carcinomas: do technical factors affect prognosis?. Japanese journal of radiology, 30(7), 560–566. https://doi.org/10.1007/s11604-012-0088-1
7 Martin, R., Irurzun, J., Munchart, J., Trofimov, I., Scupchenko, A., Tatum, C., & Narayanan, G. (2011). Optimal technique and response of doxorubicin beads in hepatocellular cancer: bead size and dose. The Korean journal of hepatology, 17(1), 51–60. https://doi.org/10.3350/kjhep.2011.17.1.51
8 Albrecht, K. C., Aschenbach, R., Diamantis, I., Eckardt, N., & Teichgräber, U. (2021). Response rate and safety in patients with hepatocellular carcinoma treated with transarterial chemoembolization using 40-µm doxorubicin-eluting microspheres. Journal of cancer research and clinical oncology, 147(1), 23–32. https://doi.org/10.1007/s00432-020-03370-z
9 Aal, A. K. A., Moawad, S., Lune, P. V., El Khudari, H., Hanaoka, M. M., Abouldahab, N., Gunn, A. J., White, J., Shoreibah, M., Li, Y., Saddekni, S., & Mahmoud, K. (2019). Survival Outcomes of Very Small Drug-Eluting Beads Used in Chemoembolization of Unresectable Hepatocellular Carcinoma. Journal of vascular and interventional radiology : JVIR, 30(9), 1325–1334.e2. https://doi.org/10.1016/j.jvir.2019.05.006
10 Balli, H., Aksungur, E., Khalatai, B., & Aikimbaev, K. (2019). Super-Selective Transarterial Chemoembolization with Doxorubicin-Loaded Drug-Eluting Beads Sized Below and Above 100 Microns in Hepatocellular Carcinoma: A Comparative Study. Journal of the Belgian Society of Radiology, 103(1), 47. https://doi.org/10.5334/jbsr.1841
11 P. Pallan, M. Wholey, R. Palacios, J. Lutz, A Mendez Castillo, A. Mehta. (2018). 4:21 PM Abstract No. 42 Transarterial chemoembolization with 40-micron drug-eluting beads: a multicenter study, a San Antonio experience. Journal of Vascular and Interventional Radiology: JVIR, 29(4), S22. https://doi.org/10.1016/j.jvir.2018.01.050
12 Greco, G., Cascella, T., Facciorusso, A., Nani, R., Lanocita, R., Morosi, C., Vaiani, M., Calareso, G., Greco, F. G., Ragnanese, A., Bongini, M. A., Marchianò, A. V., Mazzaferro, V., & Spreafico, C. (2017). Transarterial chemoembolization using 40 µm drug eluting beads for hepatocellular carcinoma. World journal of radiology, 9(5), 245–252. https://doi.org/10.4329/wjr.v9.i5.245
13 Delicque, J., Guiu, B., Boulin, M., Schwanz, H., Piron, L., & Cassinotto, C. (2018). Liver chemoembolization of hepatocellular carcinoma using TANDEM® microspheres. Future oncology (London, England), 14(26), 2761–2772. https://doi.org/10.2217/fon-2018-0237
14 Competition information derived from product literature accessed March 2023
15 She, H. L., Burgmans, M. C., Coenraadm, M., & Saraqueta, A. F. (2016). In Vivo Proof of Superselective Transarterial Chemoembolization with 40-μm Drug-Eluting Beads in a Patient with Hepatocellular Carcinoma. Cardiovascular and interventional radiology, 39(1), 137–140. https://doi.org/10.1007/s00270-015-1154-8
16 Heithaus, R., Cura, M., Waller, A., Hise, J., Daoud, Y., Lee, M. (2017). Tumor necrosis after selective transarterial
chemoembolization for hepatocellular carcinoma,
the role of bead concentration: Journal of vascular and interventional radiology : JVIR, 28(2), S124. https://doi.org/10.1016/j.jvir.2016.12.899
17 Tandem Directions for Use
18 Competition information derived from product literature accessed March 2020
19 Hung, M. L., Jiang, J., Trieu, H., Hao, F., Eghbalieh, N., Ding, P. X., & Lee, E. W. (2021). Transarterial Chemoembolization of Hepatocellular Carcinoma with Oncozene Microspheres: An Initial, Short-Term Clinical Experience-A Retrospective, Matched, Comparison Study. Life (Basel, Switzerland), 11(7), 600. https://doi.org/10.3390/life11070600
20 Lee, S. H., Lin, C. Y., Hsu, Y. C., Liu, Y. S., Chuang, M. T., & Ou, M. C. (2020). Comparison of the Efficacy of Two Microsphere Embolic Agents for Transcatheter Arterial Chemoembolization in Hepatocellular Carcinoma Patients. Cancer research and treatment, 52(1), 24–30. https://doi.org/10.4143/crt.2019.018
21 G. Laidlaw, D. Wang, D. Sze, G. Hwang, J. Louie. (2017). Clinical toxicity of irinotecan-eluting microsphere
TACE for colorectal cancer hepatic metastases:
oncozene versus LC bead: Journal of vascular and interventional radiology : JVIR, 28(2), S159.
22 Gnutzmann, D. M., Mechel, J., Schmitz, A., Köhler, K., Krone, D., Bellemann, N., Gockner, T. L., Mokry, T., Kortes, N., Sommer, C. M., Kauczor, H. U., Radeleff, B. A., & Stampfl, U. (2015). Evaluation of the plasmatic and parenchymal elution kinetics of two different irinotecan-loaded drug-eluting embolics in a pig model. Journal of vascular and interventional radiology : JVIR, 26(5), 746–754. https://doi.org/10.1016/j.jvir.2014.12.016
23 Tanaka, T., Nishiofuku, H., Hukuoka, Y., Sato, T., Masada, T., Takano, M., Gilbert, C. W., Obayashi, C., & Kichikawa, K. (2014). Pharmacokinetics and antitumor efficacy of chemoembolization using 40 µm irinotecan-loaded microspheres in a rabbit liver tumor model. Journal of vascular and interventional radiology : JVIR, 25(7), 1037–1044.e2. https://doi.org/10.1016/j.jvir.2014.04.005
24 A. Kamel Abdel Aal, S. Moawad, B. Jackson,
M. Hanaoka, C. Baalmann, N. Ertel, K. Pettibon,
A. Harris, A. Patel, Z. Lambertsen, G. Newman,
S. Saddekni. (2017). Tumor response and survival outcomes of very
small drug-eluting beads used in trans-arterial
chemoembolization for unresectable
hepatocellular carcinoma: Journal of vascular and interventional radiology : JVIR 28(2), S124-125. https://doi.org/10.1016/j.jvir.2016.12.900