US-based histotripsy therapy firm has been given the green light by the US Food and Drug Administration (FDA) to bring its device that uses sound to break up tumours to market.
The Edison System, a device intended to destroy live tumours through the use of ultrasound, found its way to market via the FDA’s De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate.
The green light for company Histosonoics comes following data from trials of the device in 13 sites across the US and Europe. Dubbed, #HOPE4LIVER, data pooled from both the US and European/UK trials were used to assess the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumours.
As part of the study histotripsy was found to have achieved both primary safety and efficacy endpoints in the pooled data where 44 subjects were evaluated for safety, and 44 tumors treated were evaluated for efficacy.
Related: TechMah CMF’s new tmCMF Solution receives US FDA clearance
The study also found a technical success rate of 95.5%, indicating that physicians would be able to precisely target and destroy liver tissue and unresectable liver tumours.
The method of histotripsy utilises focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquefies targeted liver tissue, including tumours, at sub-cellular levels.
Mike Blue, president and CEO of HistoSonics, said: “This 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.
“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. This is a fantastic day for patients who will benefit from the novel advantages of histotripsy, and I commend the FDA for working so expeditiously with us throughout the review process.”
The company believes that the novel mechanism of action of their proprietary technology may provide significant advantages to patients, including the ability of the treatment site to recover and resorb quickly.
