FDA Approves HistoSonics Trial of Non-Invasive System to Destroy Kidney Tumors

The FDA has granted Investigational Device Exemption (IDE) approval of HistoSonics’ #HOPE4KIDNEY trial to evaluate the Edison System, a non-invasive device which destroys primary renal tumors.

The Edison System uses histotripsy — focused sound energy which destroys tissue at the sub-cellular level — as an alternative to surgery.

The Edison System is currently under FDA review for treatment of liver tumors. The kidney is a logical next application for the system as “the kidney has very similar procedural and anatomical considerations as the liver, and Edison was specifically designed to treat anywhere in the abdomen,” the company said.