TANDEM™

Microspheres for Embolization

TANDEM™ Drug-Eluting Microsphere Syringes
TANDEM™ 3 ml 100µ Syringe
TANDEM™ Microspheres for Embolization is the only product offered in 40 µm sized, non-radioactive microspheres
Deliver up to 150 mg of doxorubicin-HCl or irinotecan-HCl with one 3 ml syringe

TANDEM Microspheres are precisely calibrated microspheres designed to improve procedural efficiency. Unique, calibrated sizing offers enhanced treatment options.

Key Resources

Product Value

Benefits of TANDEM Microspheres

Calibration

  • Calibration Matters: Offers the tightest calibration of any microsphere
  • 95% of all microspheres fall within the stated size variance

Drug Loading

  • Microsphere sizes remain stable during drug loading and storage; typical size change is less than 5%
  • Fast drug loading times:
    • doxorubucin-HCl (powder): 60 minutes
    • doxorubicin-HCl (solution): 120 minutes
    • irinotecan-HCl: 30 minutes
  • Capable of loading up to 50 mg of drug / ml microspheres:
    • doxorubicin-HCl Powder or solution
    • irinotecan-HCl

Product Specifications and Sizes

Size Offering

  • 3 sizes from 40 μm to 100 μm, in 2 mL or 3 mL of product per syringe
    • Only product offered in 40 μm sized, non-radioactive microspheres 
    • Only product offered in 3 mL of product per syringe
    • 3-year shelf life from date of manufacture

 

Size 2 ml product offering 3 ml product offering
40 ± 10 µm 05-0301-00402-06 05-0301-00403-06
75 ± 15 µm 05-0301-00752-06 05-0301-00753-06
100 ± 25 µm 05-0301-01002-06 05-0301-01003-06

Bibliography

Company Sponsored Clinical Trials Evaluating TANDEM and Doxorubicin or Irinotecan

 
Publication / Study Treatment Disease
State &
Staging
Number of Patients Results Endpoints
(*=Primary)

Richter et al, 2018¹
MIRACLE I

DEB-TACE with Doxorubicin HCC
ECOG: 0-2
Child-Pugh: A or B*
25 Freedom From:
30D SAEs: 92%
6M SAEs: 71%
6M tumor progression: 76%
Tumor control: 95%
12M Survival: 56% (w/o ascites 73%)
Safety (30D, 6M) ♦, Tumor progression (6M) ♦, Time to progression♦, Local tumor control, Survival (12M)
Mauri et al, 2018²
MIRACLE III
DEB-TACE with Irinotecan mCRC
ECOG: 0-1**
18 30 Day SAE-Free: 100% (18/18)
3M Tumor Control: 88.9% (17/18)
6M Tumor Control: 41.2% (7/17)
12M Tumor Control: 17.6% (3/17)
12M Survival: 44%
Safety (30D) ♦, Tumor control (3M) ♦, Secondary: Tumor control (6M, 12M), Survival (12M)
*One study patient 1/25 (4%) treated was Child-Pugh C.
**All study patients 18/18 (100%) treated were ECOG 0.
1 Richter, G., et al., Safety and Feasibility of Chemoembolization with Doxorubicin-Loaded Small Calibrated Microspheres in Patients with Hepatocellular Carcinoma: Results of the MIRACLE I Prospective Multicenter Study. Cardiovasc Intervent Radiol (2018) 41:587–593
2Mauri, G., et al., Transarterial Embolization with Small-Size Particles Loaded with Irinotecan for the Treatment of Colorectal Liver Metastases: Results of the MIRACLE III Study. Cardiovasc Intervent Radiol (2018) 41:1708–1715.
 

Randomized Controlled Trials Evaluating Doxorubicin-TACE for Treatment of HCC

Kawai, S., et al., Prospective and randomized clinical trial for the treatment of hepatocellular carcinoma--a comparison of lipiodol-transcatheter arterial embolization with and without adriamycin (first cooperative study). The Cooperative Study Group for Liver Cancer Treatment of Japan. Cancer Chemother Pharmacol, 1992. 31 Suppl: p. S1-6.

Llovet, J.M., et al., Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet, 2002. 359(9319): p. 1734-9.

Brown, K.T., et al., Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone. J Clin Oncol, 2016. 34(17): p. 2046-53.

Malagari, K., et al., Prospective randomized comparison of chemoembolization with doxorubicin-eluting beads and bland embolization with BeadBlock for hepatocellular carcinoma. Cardiovasc Intervent Radiol, 2010. 33(3): p. 541-51.

Mabed, M., et al., A randomized controlled trial of transcatheter arterial chemoembolization with lipiodol, doxorubicin and cisplatin versus intravenous doxorubicin for patients with unresectable hepatocellular carcinoma. Eur J Cancer Care (Engl), 2009. 18(5): p. 492-9.

Lammer, J., et al., Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol, 2010. 33(1): p. 41-52.

van Malenstein, H., et al., A randomized phase II study of drug-eluting beads versus transarterial chemoembolization for unresectable hepatocellular carcinoma. Onkologie, 2011. 34(7): p. 368-76.

Sacco, R., et al., Conventional versus doxorubicin-eluting bead transarterial chemoembolization for hepatocellular carcinoma. J Vasc Interv Radiol, 2011. 22(11): p. 1545-52.

Golfieri, R., et al., Randomised controlled trial of doxorubicin-eluting beads vs conventional chemoembolisation for hepatocellular carcinoma. British Journal of Cancer, 2014. 111(2): p. 255-264.

Randomized Controlled Trials Evaluating Irinotecan-TACE for Treatment of mCRC

Fiorentini, G., et al., Intra-arterial infusion of irinotecan-loaded drug-eluting beads (DEBIRI) versus intravenous therapy (FOLFIRI) for hepatic metastases from colorectal cancer: final results of a phase III study. Anticancer Res, 2012. 32(4): p. 1387-95.

Martin, R.C., 2nd, et al., Irinotecan drug-eluting beads in the treatment of chemo-naive unresectable colorectal liver metastasis with concomitant systemic fluorouracil and oxaliplatin: results of pharmacokinetics and phase I trial. J Gastrointest Surg, 2012. 16(8): p. 1531-8.

Martin, R.C., 2nd, et al., Randomized controlled trial of irinotecan drug-eluting beads with simultaneous FOLFOX and bevacizumab for patients with unresectable colorectal liver-limited metastasis. Cancer, 2015. 121(20): p. 3649-58. 

 

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