STARmed Endoluminal Ablation

A safe palliative option for unresectable
endoluminal structures

Automatic temperature-controlled endoluminal RFA

STARmed has taken RFA to the next level by introducing ELRATM, Endo Luminal Radiofrequency Ablation catheter, to help patients with hepatic, biliary, or pancreatic unresectable endoluminal lesions. It is a flexible RFA electrode with an automatic Temperature Sensing System, offering interventional radiologists a minimally invasive palliative care option to enhance patients’ quality of life.

~20%1

5-year survival rate for cholangiocarcinoma (CCA), but varies based on the state of the cancer at diagnosis

~70%2

of patients with CCA (Cholangiocarcinoma) have unresectable disease at presentation

<50%3

of patients will have stent occlusion in the first 6 to 8 months.

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Percutaneous approach

The ELRA Electrode is an innovative RFA catheter inserted over the wire (OTW), to ablate tissues in the hepatopancreatobiliary ducts. It is designed to effectively clear obstructions and tumor growth through a percutaneous approach.

Complete ablation

Under fluoroscopic guidance, the ELRA electrode is advanced into the targeted segment of the duct to achieve ablations.4 With 4 varying exposure lengths, ELRA completes ablations for varying lengths of stricture safely and effectively.5

Before RFA

After RFA

Clinically proven results

According to multiple prospective single or multicenter studies, temperature-controlled intraductal RFA using the ELRA platform appeared feasible and safe with acceptable biliary patency. Temperature-controlled RFA avoids excessive heating and significant vessel or bile duct injury. 6,7

Versatile applications

As RFA produces promising results in patients with a variety of gastrointestinal and hepatopancreatobiliary pathologies, physicians have been exploring different applications of ELRA to enhance palliative care for patients.

PRODUCT INDICATIONS

The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts

  1. American Cancer Society. (2022). Bile duct cancer (cholangiocarcinoma) statistics. https://www.cancer.org/cancer/bile-duct-cancer/about/key-statistics.html
  2. Banales, J.M., Marin, J.J.G., Lamarca, A. et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol 17, 557–588 (2020). https://doi.org/10.1038/s41575-020-0310-z
  3. Figueroa-Barojas P, Bakhru MR, Habib NA, et al. Safety and efficacy of radiofrequency ablation in the management of unresectable bile duct and pancreatic cancer: a novel palliation technique. J Oncol. 2013;2013:910897. doi:10.1155/2013/910897
  4. Hendriquez R, Keihanian T, Goyal J, Abraham RR, Mishra R, Girotra M. Radiofrequency ablation in the management of primary hepatic and biliary tumors. World J Gastrointest Oncol 2022; 14(1): 203-215 [PMID: 35116111 DOI: 10.4251/wjgo.v14.i1.203]
  5. Kang H, Chung MJ, Cho IR, Jo JH, Lee HS, Park JY, Park SW, Song SY, Bang S. Efficacy and safety of palliative endobiliary radiofrequency ablation using a novel temperature-controlled catheter for malignant biliary stricture: a single-center prospective randomized phase II TRIAL. Surg Endosc. 2021 Jan;35(1):63-73. doi: 10.1007/s00464-020-07689-z. Epub 2020 Jun 2. PMID: 32488654.
  6. Laleman W, van der Merwe S, Verbeke L, Vanbeckevoort D, Aerts R, Prenen H, Van Cutsem E, Verslype C. A new intraductal radiofrequency ablation device for inoperable biliopancreatic tumors complicated by obstructive jaundice: the IGNITE-1 study. Endoscopy. 2017 Oct;49(10):977-982. doi: 10.1055/s-0043-113559. Epub 2017 Jul 21. PMID: 28732391.
  7. Lee YN, Jeong S, Choi HJ, Cho JH, Cheon YK, Park SW, Kim YS, Lee DH, Moon JH. The safety of newly developed automatic temperature-controlled endobiliary radiofrequency ablation system for malignant biliary strictures: A prospective multicenter study. J Gastroenterol Hepatol. 2019 Aug;34(8):1454-1459. doi: 10.1111/jgh.14657. Epub 2019 Apr 14. PMID: 30861593.