AngioDynamics Increases Physician Access to NanoKnife System

AngioDynamics Inc. has expanded the European indications for its NanoKnife System to include soft tissue ablation for tumors of the liver, pancreas, kidney, and prostate, including in patients with intermediate-risk prostate cancer.

The expanded indications aim to increase physician access to the NanoKnife System’s irreversible electroporation (IRE) technology across key oncologic applications, supporting treating patients with tumors that may be difficult to resect or located near critical structures.

The NanoKnife System uses IRE, a non-thermal ablation technology designed to destroy tumor cells while preserving critical surrounding anatomy such as blood vessels, bile ducts, and nerves. This differentiated mechanism of action makes it particularly suited for tumors located in complex anatomical regions, such as the pancreas and liver.

“NanoKnife prostate continues to gain clinical traction, and we remain committed to advancing that indication globally,” said Laura Piccinini, senior vice president and general manager, Cardiovascular & International. “The expansion of additional organ indications in Europe underscores the broader potential of IRE technology and strengthens NanoKnife as a scalable platform for complex tumor ablation. Our goal is to ensure physicians have access to differentiated tools that expand treatment options for patients across multiple disease states.”

A growing body of clinical evidence supports the use of the NanoKnife System’s IRE technology across multiple solid tumor indications. Prospective and multicenter studies have demonstrated procedural feasibility and encouraging clinical outcomes in metastatic colorectal cancer,¹ liver and pancreatic cancer,^2,3 hepatocellular carcinoma,⁴ and renal tumors. Comparative and real-world analyses continue to reinforce IRE’s safety profile and expanding clinical utility in anatomically challenging disease states.^5,6,7

Collectively, this expanding evidence base has contributed to increasing physician adoption of IRE across Europe and other global markets, according to AngioDynamics bigwigs. Europe accounts for approximately 28% of global IRE procedures. Annual IRE procedures are estimated to have surpassed 45,000 globally and continue to grow, supported by rising cancer incidence, expanding physician adoption, technological advancements in image guidance, and strong demand for minimally invasive treatment options.⁸

The expanded indications position the NanoKnife System to participate more broadly across this growing European market and reinforce its role as a multi-organ tumor ablation platform.

To further support clinical adoption and long-term evidence development, AngioDynamics will initiate the LIVER-IRE Global Registry in collaboration with Professor Ajith Siriwardena, M.D., at the University of Manchester in the United Kingdom. The registry is designed to prospectively evaluate outcomes in patients undergoing IRE treatment for liver tumors and contribute to the body of real-world clinical data supporting multi-organ applications of the NanoKnife System technology.

“Irreversible electroporation offers an important treatment consideration for patients with liver tumors located near critical structures,” Siriwardena stated. “The LIVER-IRE Registry will help further characterize outcomes in real-world practice.”

The NanoKnife System uses IRE technology to destroy targeted cells without the use of thermal energy by delivering high-voltage pulses, creating permanent nanopores within the cell membrane. This stimulus induces an apoptotic-like cellular death in the targeted tissue, resulting in a complete ablation of the targeted tissue.⁶

In the United States, the NanoKnife System with six outputs is indicated for the surgical ablation of soft tissue, including prostate tissue. But in Canada, the NanoKnife System is a medical device for cell membrane electroporation, a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electric field acts as a physical stimulus, bringing about alterations in cell membranes that result in increased permeability. In the European Union, the NanoKnife System is indicated for ablation of soft tissue and tumors in the pancreas, kidney, liver, or prostate, including intermediate-risk prostate cancer.

AngioDynamics is a medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving patient quality of life.

References
¹ Meijerink MR, Ruarus AH, Vroomen LGPH, et al. Irreversible electroporation to treat unresectable colorectal liver metastases (COLDFIRE-2): A Phase II, two-center, single-arm clinical trial. Radiology. 2021;299(2):470-480. doi:10.1148/radiol.2021203089
² https://www.angiodynamics.com/studies/direct-study/
³ Ruarus AH, Vroomen LGPH, Geboers B, van Veldhuisen E, Puijk RS, Nieuwenhuizen S, Besselink MG, Zonderhuis BM, Kazemier G, de Gruijl TD, van Lienden KP, de Vries JJJ, Scheffer HJ, Meijerink MR. Percutaneous irreversible electroporation in locally advanced and recurrent pancreatic cancer (PANFIRE-2): a multicenter, prospective, single-arm, phase II study. Radiology. 2020;294(1):212-220. doi:10.1148/radiol.2019191109.
⁴ Cribbs KA, Baisley WT, Lahue BJ, Peddu P. Clinical and safety outcomes in unresectable, very early and early-stage hepatocellular carcinoma following irreversible electroporation (IRE) and transarterial chemoembolization (TACE): a systematic literature review and meta-analysis. PLoS One. 2025;20(4):e0322113. doi:10.1371/journal.pone.0322113.
⁵ Frühling P, Stillström D, Holmquist F, Nilsson A, Freedman J. Irreversible electroporation of hepatocellular carcinoma and colorectal cancer liver metastases: a nationwide multicenter study with short- and long-term follow-up. Eur J Surg Oncol. 2023;49(11):107046. doi:10.1016/j.ejso.2023.107046.
⁶ Gupta P, Maralakunte M, Sagar S, Kumar-M P, Bhujade H, Chaluvashetty SB, Kalra N. Efficacy and safety of irreversible electroporation for malignant liver tumors: a systematic review and meta-analysis. Eur Radiol. 2021;31(12):6511-6521. doi:10.1007/s00330-021-07742-y.
⁷ Wah TM, Lenton J, Smith J, Bassett P, Jagdev S, Ralph C, Vasudev N, Bhattarai S, Kimuli M, Cartledge J. Irreversible electroporation (IRE) in renal cell carcinoma (RCC): a mid-term clinical experience. Eur Radiol. 2021;31(10):7491-7499. doi:10.1007/s00330-021-07846-5.
⁸ https://www.globalgrowthinsights.com/blog/irreversible-electroporation-ablators-companies-837