FDA Paves Way for New Liver Tumor Treatment with Histotripsy

The U.S. Food and Drug Administration recently authorized a new technology called histotripsy to treat tumors in the liver, including neuroendocrine tumors. The noninvasive Edison® system developed by HistoSonics® uses sound waves to destroy liver tumors.

The FDA authorization was based partly on the results from the #HOPE4LIVER clinical trial conducted at 13 sites in the US and Europe. The trial evaluated the efficacy and safety of the Edison system to treat primary or metastatic liver tumors.

The Edison is the first and only histotripsy platform available in the United States.

How histotripsy works

Histotripsy uses sound waves to treat liver tumors. It is noninvasive, so no needles, radiation, or surgery is required.

During a histotripsy procedure, a physician uses an ultrasound probe or device to deliver concentrated ultrasound waves to the specific tissue needing treatment. The sound waves are strong but directed only to the tumor to be treated, sparing surrounding healthy tissue and blood vessels.

The sound waves create tiny bubbles within the cells of the tumor. The bubbles then expand and collapse quickly, releasing energy that breaks down the cells of the tumor tissue. Over time, the body’s immune system removes the debris from the broken-down tumor tissue.

Benefits of histotripsy

HistoSonics believes its technology may provide significant advantages to patients, including the ability of the treatment site to recover quickly. In addition, the platform has the unique benefit of allowing physicians to monitor the destruction of tumor tissue under continuous real-time visualization and control.

“Histotripsy is a very exciting potential advancement in the minimally invasive treatment of liver tumors,” says Osman Ahmed, MD, an interventional radiologist at University of Chicago Medicine. “To be able to treat tumors without radiation or needles has the potential to be a game changer from a safety standpoint. Its mechanism of action also allows us to be even more precise and effective when treating tumors close to critical structures like blood vessels or bile ducts.”

Dr. Ahmed discussed histotripsy in his presentation, “Interventional Radiology Treatments for Primary Tumors and Liver Metastases,” during NETRF’s 2023 Know Your NETs Virtual Conference for NET Patients and Caregivers.

Availability of histotripsy for patients

HistoSonics is working to make the Edison system commercially available as well as expanding its application to other organs like the kidney and pancreas.

As the system rolls out more widely, patients interested in learning more about histotripsy should speak to their doctor or cancer center about the procedure and its availability.