Focused Ultrasound System Gains CE Mark for Liver Tumor Treatment

Tumor location, underlying liver disease, and other clinical factors can limit treatment options while increasing the risk of complications. As a result, hepatology and oncology teams continue to seek noninvasive, image-guided therapies that minimize damage to healthy tissue. A new system now offers focused-ultrasound histotripsy for liver tumors in Europe following CE Mark approval.

HistoSonics’ Edison Histotripsy System has received CE Mark approval in Europe, enabling commercialization across the region and in other markets that recognize the CE Mark. The platform is intended for the non-invasive, image-guided destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors. The Edison Histotripsy System also received FDA De Novo clearance in October 2023.

The technology uses the mechanical properties of focused ultrasound, known as histotripsy, to liquefy and destroy unwanted tissue and tumors in a single procedure. It requires no incisions or radiation and is described as potentially associated with fewer side effects than traditional therapies. Image guidance is designed to support precise targeting while limiting damage to surrounding healthy liver parenchyma.

Regulatory clearance was supported by a growing body of clinical evidence. The #HOPE4LIVER pivotal trial enrolled patients at hospitals across the United States and Europe, including sites in Germany, Italy, Spain, and the United Kingdom. The trial demonstrated a 90% local tumor control rate at 12 months across treated tumor types, with a low complication rate. Additional long-term follow-up data are being collected to further validate outcomes in broader real-world use.

A phased commercial rollout is planned in Europe, beginning with select centers of excellence specializing in liver tumor treatment. The Edison System is intended for the noninvasive mechanical destruction of liver tumors using histotripsy; it is not approved for the treatment of any specific disease, including cancer, and regulatory agencies have not assessed outcomes such as local tumor control, five-year survival, or overall survival. The device should be used only by physicians who have completed company-provided training, with application guided by the clinical judgment of a qualified practitioner.

“Receiving CE Mark approval marks another historic milestone for HistoSonics and for patients across Europe. Histotripsy represents a fundamentally new way to treat patients, using focused ultrasound to mechanically destroy tumors and tissue without the invasiveness or toxicity of traditional procedures,” said Mike Blue, Chairman and Chief Executive Officer, HistoSonics. 

“With the Edison System now approved in Europe, we look forward to working with leading clinical centers throughout the EU and UK to expand access to this non-invasive treatment option, and especially for patients currently suffering from the tumors in their liver and who have very few if any options,” added Blue.