This week, the U.S. Food and Drug Administration gave the green light to a device that uses ultrasound waves to crush cancerous tumors in the liver.
HDN Newsroom
This technique, which does not require needles, injections, knives or drugs, is called histotripsy and is developed by the company HistoSonics.
It is worth noting that this approval comes after the results of a series of clinical trials that showed that it can effectively destroy liver tumors while being significantly safer for patients. All that remains is the purchase of this device on behalf of hospitals, giving hope to our fellow human beings who suffer from this condition.
The way it works is very simple. More specifically, it works with pulses of high-energy ultrasonic waves in a volume, which creates clusters of microbubbles inside. When bubbles form and collapse, they strain the cells and tissues around them, allowing them to break down the internal structure of the tumor, leaving behind scattered pieces that the immune system can then fight.
Placed over the abdomen area is a head that looks great like virtual reality glasses. Doctors try to locate the tumor and then lock themselves in the area and load the sound waves. The procedure is reportedly quick and painless, while the recovery period after the procedure is short.
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.
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.
Although the approval of the device is the first big step in expanding options for cancer treatments, the use of sound waves in medicine is not new. Another platform called Insightech's Exablate Prostate was approved by the FDA for trials in prostate cancer patients.
