HistoSonics has received CE mark approval for its Edison histotripsy system, enabling the commercial launch of its non-invasive ultrasound platform for the treatment of liver tumors across Europe.
The image-guided system uses focused ultrasound to destroy liver tumors without surgery and is the first regulatory-cleared histotripsy device. The approval was supported by data from the #HOPE4LIVER pivotal trial, which demonstrated 95.5% complete tumor coverage and 90% local tumor control at 12 months.
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Following the approval, HistoSonics plans a phased commercial rollout across European centers specializing in liver cancer treatment.
CEO Mike Blue said:
“With the Edison system now approved in Europe, we look forward to working with leading clinical centres throughout the EU and UK to expand access to this non-invasive treatment option.”
The CE mark builds on the system’s FDA De Novo authorization for liver tumors in 2023. HistoSonics is also evaluating Edison for additional indications, including kidney tumors, benign prostatic hyperplasia (BPH), and pancreatic cancer.
