HistoSonics, manufacturer of the Edison System and novel histotripsy therapy platforms, announced marketing authorization of its platform via the U.S. Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous premarket review pathway for medical devices with no existing predicate.
Marketing authorization makes Edison the first and only histotripsy platform available in the United States, according to HistoSonics.The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
FDA authorization was based, in part, on data from trials in 13 sites across the US and Europe. Data pooled from both the US and European trials were used to assess the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumors.
“This is HistoSonics’ most meaningful milestone to date and represents over two-decades of tireless efforts, from its inception at the University of Michigan in 2001, overcoming what was once thought to be impossible – integrating the many complexities of histotripsy into a completely non-invasive clinical platform,” said Mike Blue, president, and CEO of HistoSonics. “We have been thoughtfully adding professionals with deep domain experience in operations, market development and education and are prepared to begin scheduling physician training immediately.”
Histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted liver tissue, including tumors, at subcellular levels. HistoSonics’ Edison System uses proprietary technology and advanced imaging to deliver personalized, non-invasive histotripsy treatments with precision and control. HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.
“As a surgeon, it’s rewarding to be able to offer a procedure where we can precisely destroy liver tumors without using a scalpel or needles, hopefully enabling the patient’s quick recovery while avoiding certain complications like surgical site infections or radiation illness common with other modalities,” said Joe Amaral MD, VP medical affairs for HistoSonics. “Based on the data and patient experiences in our studies we are confident histotripsy will have a meaningful impact for patients suffering from unresectable liver disease, including liver tumors, and we look forward to the role histotripsy will play in treatment strategies going forward.”