EDISON
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Histotripsy System
Edison* is the world’s first non-invasive therapy system based on Histotripsy, an innovative form of focused ultrasound that uses high-amplitude, very short pulses to mechanically destroy targeted tumor tissue.
Through acoustic cavitation, the system generates a cloud of microbubbles (bubble cloud) that rapidly expand and collapse, precisely liquefying tumor cells without heat or ionizing radiation.
Edison integrates real-time ultrasound imaging with an automated therapy arm, enabling a completely external, incision-free procedure in a single session.
*Investigational use only, not CE marked.
HistoSonics products are used under study protocol and still not available for sale in Europe
The Edison System consists of three main components
User interface control panel
Central console with a touchscreen display for procedure planning via integrated software.
Automated treatment arm
Robotic arm that moves the treatment head in six degrees of freedom. It dynamically follows the planned treatment volume throughout the procedure, as defined during the planning phase.
Treatment head
Integrates the therapy transducer for bubble cloud generation and the imaging ultrasound probe with settings specifically optimized for Histotripsy. Enables continuous real-time
ARE YOU A HEALTHCARE PROFESSIONAL?
The following content is intended for healthcare professionals as it concerns products categorised as medical devices that must be used or operated by professionals in the medical/healthcare sector.
N.B.: Pursuant to and for the purposes of Art. 76 D.P.R. 445/2000, aware of the responsibility and the civil and criminal consequences provided for in case of false statements and/or formation or use of false documents, as well as in case of the exhibition of documents containing data no longer true, I confirm that I am a HEALTH CARE OPERATOR.
OPERATIONS
Edison follows a three-phase workflow:
- Localize
- Plan
- Treat
During localization, the ultrasound image is displayed in real time, and the robotic arm is guided via software to the previously identified target lesion. When needed, MRI/CT images are overlapped with fusion technology with live ultrasound in multiplanar views. During planning, the clinician defines the target volume with contours overlaid on the live image; the system calibrates the energy at 7 target points, automatically calculating the energy to be delivered across the entire treatment volume. During the treat phase, delivery is fully automated: the arm follows the planned pattern while the bubble cloud is continuously monitored with ultrasound. The physician retains full control throughout, with the ability to pause and make real-time adjustments to the plan. The mechanism of action is non-thermal, non-ionizing, and non-invasive – purely mechanical – destroying the tumor at the cellular and sub-cellular level.
Clinical Advantages
- Step-by-step guided workflow that simplifies planning and reduces the learning curve
- Real-time ultrasound monitoring of the bubble cloud throughout the procedure, providing immediate visual confirmation of therapeutic action
- Preservation of critical structures: the mechanism of action has been designed to spare collagenous vessels, bile ducts, and the hepatic capsule
- Multi-tumor treatment within a single session
- Multidisciplinary platform: usable by hepatobiliary surgeons, interventional radiologists, surgical oncologists, and transplant surgeons
- Compatible with concomitant therapies: patients may be on systemic therapy or anticoagulants during treatment, expanding the eligible patient pool
Advantages for patients
- Completely non-invasive: no incisions, no scarring
- Single treatment session in most cases
- No radiation-related toxicities: purely mechanical, non-ionizing, and non-thermal mechanism of action
- Majority of patients return to daily activities quickly post-procedure
- Does not preclude future treatments
- Applicable to patients who are unresectable or ineligible for more invasive therapies
Clinical Applications
Edison is currently approved for the treatment of primary and secondary liver tumors. Its applications are expanding – on an investigational basis – to other solid organs:
- Pancreatic oncology (investigational use — GANNON trial)
- Renal oncology (investigational use — HOPE4KIDNEY trial)
- Urologic oncology (investigational use — WOLVERINE trial)
Review of scientific and clinical research regarding histotripsy
The following is a representative sample of published literature regarding histotripsy of liver tumors and is intended for healthcare professionals seeking information about clinical evidence on histotripsy.
Histotripsy is a novel procedure for the non-invasive destruction of liver tumors. Prospective studies were used to demonstrate safety and effectiveness and obtain an FDA marketing authorization. Emerging literature continues to build upon those early studies to further inform the benefit/risk profile of hepatic histotripsy while documenting additional use cases from treating physicians.
HistoSonics provides the following scientific publications as representative but not exhaustive uses of histotripsy. All articles are subject to limitations in their ability to substantiate specific performance claims, particularly regarding long-term efficacy. Many articles are retrospective in nature with a small sample size. Patients in these articles also presented with liver tumors from a very heterogeneous origin (primary liver tumors and liver metastases from a large variety of primary organs). Many patients documented in these articles had multiple liver tumors, not all of which were targeted for treatment. Additionally, many patients received concomitant or adjunctive therapies. All these factors confound drawing specific conclusions about hepatic histotripsy beyond the general safety and effectiveness of destroying targeted liver tumors.
HistoSonics is providing this information as a free exchange of medical and scientific information. These articles represent a sample of clinical evidence and are available at the provided links. Some of the articles may involve discussions about specific disease cohorts or discuss possible uses of histotripsy that are futuristic and not yet approved by FDA. By including these articles, HistoSonics is not stating or implying the Edison System is effective at treating any specific disease. Nor is the company intending to make or imply any additional claims beyond those currently cleared within its device labeling.
PROSPECTIVE CLINICAL TRIALS
The #HOPE4LIVER single-arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors: 1-year Update of Clinical Outcomes.
Ziemlewicz TJ, et al. Ann Surg. 2025;282(6):908–16.
The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors.
Mendiratta-Lala M, et al. Radiology. 2024;312(3):e233051.
First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study.
Vidal-Jove J, et al. Int J Hyperthermia. 2022;39(1):1115–1123.
HISTOTRIPSY RESEARCH ARTICLES
SYSTEMATIC REVIEW
Histotripsy for liver tumours: a systematic review and meta-analysis of current clinical evidence.
Wehrle CJ, et al. eClinicalMedicine. 2026;95:103926.
RETROSPECTIVE STUDIES – MULTICENTER
The first international experience with histotripsy: a safety analysis of 230 cases.
Wehrle CJ, et al. J Gastrointest Surg. 2025;29(4):102000.
Local Tumor Control of Liver Tumors After Histotripsy: A Preliminary National Multicenter Study.
Wehrle CJ, et al. JCO Oncol Pract. 2025.
Histotripsy of Liver Metastases: Short-Term Safety and Imaging Findings.
Mabud TS, et al. Cardiovasc Intervent Radiol. 2025;48(11):1594–1603.
Prospective analysis on the outcomes of histotripsy for primary and metastatic liver tumours.
Chan AC, et al. Int J Surg. 2026;112(2):3287–3296.
Histotripsy of Pancreatic Cancer Liver Metastases: Early Outcomes and Imaging Findings.
Mabud TS, et al. World J Surg. 2025;49(7):1899–1902.
First FDA approved experience with histotripsy for liver cancer management.
Jimenez-Soto C, et al. Int J Surg. 2025.
Histotripsy for neuroendocrine liver metastases: Early single-institution outcomes and safety.
Liu E, et al. Surgery. 2026;194:110084.
SINGLE CENTER
The first full year of histotripsy for liver tumors: Local tumor control and preliminary oncologic efficacy.
Wehrle CJ, et al. Surgery. 2026;191:109898.
CASE STUDIES / LETTERS TO THE EDITOR / REVIEWS
Use of Histotripsy to Rapidly Relieve Biliary Obstruction in a Patient with Recurrent Hilar Cholangiocarcinoma.
Bridging therapy with histotripsy prior to liver transplantation for hepatocellular carcinoma: a first case report.
Distant Tumor Response in the Pelvis After Histotripsy of a Metastatic Sarcoma of the Liver in a Patient With Differentiated Liposarcoma.
Histotripsy for portal vein tumor thrombus in a patient with hepatocellular carcinoma: a case report.
Vascular complications following histotripsy of hepatocellular carcinoma.
Hyperprogression and Systemic Metastasis of Cholangiocarcinoma after Histotripsy Therapy.
Surgery Without Scalpel: Histotripsy as a Non-Invasive and Non-Thermal Modality for Liver Tumor Ablation.
Breaking Barriers with Sound: The Implementation of Histotripsy in Cancer.
Histotripsy of Liver Tumors: Patient Selection, Ethical Discussions, and How We Do It.
Acute Kidney Injury Following Hepatic Histotripsy.
Vascular Injury after Histotripsy: A Case Series of Hemorrhage and Pseudoaneurysm Complications in Human Patients.
Histotripsy for multifocal breast cancer liver metastases with early complete metabolic response: a case report.
Observed Immune Response Following Histotripsy in Metastatic Hepatocellular Carcinoma.
PRECLINICAL STUDY SUBSET
Effects of tissue mechanical properties on susceptibility to histotripsy-induced tissue damage.
Histotripsy: the first noninvasive, non-ionizing, non-thermal ablation technique based on ultrasound.
Clinical translation of abdominal histotripsy: a review of preclinical studies in large animal models.
A comparison study of microwave ablation vs. histotripsy for focal liver treatments in a swine model.
These studies are a representative sample of preclinical evidence that are relevant to the current use of histotripsy in clinical practice.
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