US-based medical technology company HistoSonics has secured the US Food and Drug Administration (FDA) marketing authorisation for its Edison Histotripsy System.
The US regulator granted the marketing authorisation under its De Novo Classification Request process, a pre-market review pathway for medical devices with no existing predicate.
The Edison histotripsy system is indicated for the non-invasive destruction of liver tumours using a non-thermal, mechanical process of focused ultrasound.
Histotripsy is a treatment method where focused sound energy is used to produce controlled acoustic cavitation that mechanically destroys targeted liver tissue, including tumours.
HistoSonics said that its Edison System leverages unique technology and advanced imaging to deliver personalised, non-invasive histotripsy treatments with precision and control.
The technology’s novel mechanism of action may provide significant advantages to patients, including rapid recovery and resorption of the treatment site.
Also, the histotripsy platform enables physicians to monitor the destruction of tissue under continuous real-time visualisation and control, unlike any modality that exists today.
With the FDA marketing authorisation, Edison became the first and only histotripsy platform available in the US, said the US-based medical technology company.
HistoSonics president and CEO Mike Blue said: “The company noted it has expanded its commercial and operational capacity over the previous year in preparation for commercial activities.
“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 FDA de novo marketing authorisation was partly supported by data from the HOPE4LIVER clinical trials, conducted at 13 trial sites across the US and Europe.
Data pooled from both the US and European trials were used to validate the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumours.
Histotripsy achieved both primary safety and efficacy endpoints in the pooled data where 44 subjects were evaluated for safety and 44 tumours treated were evaluated for efficacy.
HistoSonics medical affairs VP Joe Amaral said: “As a surgeon, it’s rewarding to be able to offer a procedure where we can precisely destroy liver tumours 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.
“Based on the data and patient experiences in our studies, we are confident histotripsy will have a meaningful impact on patients suffering from unresectable liver disease, including liver tumours, and we look forward to the role histotripsy will play in treatment strategies going forward.”
