HistoSonics Secures CE Mark for Edison® Histotripsy System in Europe
HistoSonics has received CE Mark approval for its Edison® System, enabling the commercialisation of its non-invasive histotripsy technology in Europe and other markets recognising the certification.
The Edison System is an image-guided platform designed to destroy liver tumours, including unresectable tumours that cannot be removed through surgery.
The system uses focused ultrasound-based histotripsy technology to mechanically break down targeted tissue without invasive procedures, radiation, or thermal energy.
The regulatory approval was supported by clinical evidence demonstrating the system’s safety and effectiveness in treating liver tumours.
Data from the HOPE4LIVER pivotal trial, conducted across healthcare centres in the United States and Europe, showed a 90% local tumour control rate at 12 months across treated tumour types, along with a low complication rate.
Histotripsy provides a potential alternative for patients who may not qualify for traditional surgical or ablation procedures due to tumour location, liver conditions, or other clinical challenges.
The technology is designed to target tumours while preserving surrounding healthy tissue.
Following the CE Mark approval, HistoSonics will begin a phased commercial rollout of the Edison System in selected European centres specialising in liver tumour treatment.
The system previously received FDA De Novo clearance in the United States in 2023.
