HistoSonics wins CE Mark approval for Edison System liver tumor device

HistoSonics announced it has received CE Mark approval in Europe for its Edison System, clearing the way for commercialization of the company's non-invasive histotripsy technology across Europe and other markets that recognize the CE Mark.

The Edison System is a non-invasive, image-guided platform intended for the destruction of liver tumors, including partial or complete destruction of unresectable liver tumors. The device uses histotripsy — the mechanical properties of focused ultrasound — to liquefy and destroy unwanted tissue and tumors in a single procedure, without invasive intervention or radiation, according to the company.

The approval follows a growing number of regulatory clearances for the platform and was supported by clinical evidence demonstrating the safety and effectiveness of histotripsy for treating liver tumors, the company said. Clinical studies of the Edison System have shown the ability to precisely target and destroy liver tumors while maintaining a favorable safety profile, avoiding many complications associated with conventional thermal ablation or surgical approaches, per HistoSonics.

The CE Mark clearance was based in part on data from the #HOPE4LIVER pivotal trial, which enrolled patients across the United States and Europe, including hospitals in Germany, Italy, Spain and the United Kingdom. According to HistoSonics, the trial demonstrated a 90% local tumor control rate at 12 months across the tumor types treated, with a low complication rate. Additional long-term follow-up data are being collected to further validate those outcomes in broader real-world use, the company said.

"Receiving CE Mark approval marks another historic milestone for HistoSonics and for patients across Europe," Mike Blue, chairman and CEO of HistoSonics, said in a statement. "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."

Blue said the company looks forward to working with leading clinical centers throughout the European Union and United Kingdom to expand access to the non-invasive treatment, particularly for patients with liver tumors who currently have few if any options.

Liver tumors remain a significant global health challenge, and many patients are not candidates for surgery or traditional ablation procedures because of tumor location, underlying liver disease or other clinical factors, the company noted. Histotripsy is designed to precisely target tumors while minimizing damage to surrounding healthy tissue, according to HistoSonics.

The Edison System received FDA De Novo clearance in the U.S. in October 2023. HistoSonics said it plans to initiate a phased commercial rollout of the system in Europe, beginning with select centers of excellence specializing in liver tumor treatment.

The company noted that the Edison System is not approved for the treatment of any specific disease, including cancer, and that regulatory agencies have not assessed outcomes such as local tumor control, five-year survival or overall survival. The device is intended for use only by physicians who have completed HistoSonics-provided training, guided by the clinical judgment of a qualified, appropriately trained physician, according to the company.

HistoSonics is a privately held medical device company. The company is currently focused on commercializing the Edison System in the U.S. and select global markets for liver treatment while expanding histotripsy applications into other organs, including the kidney, pancreas and prostate.

Growing focus on non-invasive tumor treatment

The European approval arrives as the broader interventional oncology field continues shifting toward non-invasive and minimally invasive alternatives to surgery and traditional thermal ablation. Health systems have increasingly sought treatment options that reduce procedural risk, shorten recovery time and expand eligibility to patients who are poor candidates for resection because of tumor location, liver function or comorbidities.

That shift has coincided with expanded digital integration in the operating room and interventional radiology suite, as device makers pair novel therapies with connected platforms designed to support training, remote guidance and case review as adoption scales across new sites. For physicians managing patients with unresectable liver disease, the trend suggests a widening menu of image-guided options intended to complement — rather than replace — surgical and interventional standards of care, with outcomes data continuing to accumulate as real-world use expands beyond initial pivotal trial populations.