HistoSonics’ Novel Histotripsy Platform Earns CE Mark in Europe

HistoSonics has received CE Mark approval for its Edison Histotripsy System, allowing the company to commercialise its non-invasive technology in Europe and other markets that recognise the certification.

The Edison System is an image-guided platform designed to mechanically destroy liver tumours, including unresectable tumours. 

It uses focused ultrasound to generate mechanical forces that break down targeted tissue without conventional surgery, thermal ablation or ionising radiation.

The European approval was supported by clinical evidence from the HOPE4LIVER pivotal trial, which included patients treated at centres across the United States and Europe. 

Results from the study reported a 90 per cent local tumour control rate at 12 months across the tumour types treated, alongside a low complication rate.

Histotripsy is intended to target tumours while limiting damage to surrounding healthy tissue. 

This approach may offer an additional treatment option for patients who are not suitable candidates for surgery or conventional ablation because of tumour location, underlying liver conditions or other clinical factors.

HistoSonics plans to begin a phased commercial rollout in Europe, initially focusing on selected centres specialising in liver tumour treatment. The Edison System previously received FDA De Novo clearance in the United States in 2023.