Quantum Surgical has scored FDA clearance for its Epione robot, which is designed to perform minimally invasive liver cancer treatment.

The robotic-assisted system plans, targets, delivers and confirms the results of percutaneous tumor ablation, a procedure that entails inserting a needle through the skin of the tumor to destroy it. With its nod from the FDA, Quantum Surgical can sell its solution to U.S. providers who can use it to treat early-stage liver disease, which affects more than three million people annually worldwide and is a leading cause of cancer-related deaths.

While proven through research to be effective, the treatment is underutilized, company co-founder and CTO Lucien Blondel, told HCB News. "Radiologists are challenged by limitations in current imaging and lack of tools for ablation treatment planning and confirmation. Additional challenges include navigating critical structures, managing patient respiration and placing multiple needles to ensure adequate treatment margins of the tumor. We believe robotics combined with advanced preplanning and confirmation software will expand access and adoption of this critical therapy for the treatment of liver cancer."

Percutaneous tumor ablation is a proven therapy that is underutilized today, and Epione will allow expansion of this minimally invasive treatment to more patients battling liver cancer,” said Nishita Kothary, a professor of radiology at Stanford University Medical Center, in a statement.

In any procedure, Epione starts by defining tumor margins, selecting ablation modalities and using 2D/3D image fusion software to visualize the ablation zone. It offers six degrees of freedom and dexterity to assess difficult trajectories when targeting abdominal tumors. It also synchronizes respiratory monitors and places the ablation probe in a safety lock needle guide before it delivers treatment. Among the ablative technologies that surgeons can use with Epione are radiofrequency, microwave, cryoablation and irreversible electroporation.

Following treatment, a post-op CT is taken and compared with pre-op images to confirm results. Tumor volume is compared to the ablation zone to determine if the procedure was successful. The open solution is compatible with any imaging system, and clinical data from France’s Gustave Roussy Cancer Center and Montpellier University Hospital supports treatment with the system for primary and secondary liver tumors.

Ablation as a first treatment option for very-early and early-stage liver cancer is supported by the Barcelona Clinic Liver Cancer (BCLC) treatment criteria as an alternative to surgery. Beyond the BCLC criteria, data supports the procedure as a first line treatment that can potentially cure cancer when surgery is not an option. Less than 30% of patients with liver tumors are eligible for surgical resection due to the presence of multiple tumors, underlying poor liver function, or general health issues that limit the success of surgery.

"Interventional radiologists are already treating many cancer patients on a daily basis in a variety of organs beyond the liver," said Blondel. "Our intent is to expand the use of Epione to organs such as kidney, lung and bone where percutaneous ablation has demonstrated clinically proven benefits to the patient."

He adds that the company plans to add AI features that support treatment preplanning and confirmation phases by automating manual tasks performed by physicians. "AI shows great promise streamlining medical imaging tasks while bringing quality and consistency."