CLINICAL EVIDENCE PORTFOLIO

This content is intended for healthcare professionals. I acknowledge that I am a healthcare professional seeking information on the scientific and clinical research of histotripsy.
DISCLAIMER:
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.