Fda APPROVAL, AN UPDATE FRom edap
EDAP, the manufacturer of the Albatherm HIFU device, is currently running the FDA trial.
We recently met with Marc Oczachowski, EDAP's CEO, to discuss the current position of their application and the likely timeline for the approval process.
At present, all trial patients have completed their two year follow-up and EDAP is compiling the data into a report for submission to the FDA. In addition to the US trial data, this report is likely to include additional data from research performed in France, Germany, Canada and other countries around the world where HIFU treatments are already being performed.
This report will be submitted to the FDA within the next few months. The FDA will review the report - likely to be in excess of 1,000 pages - and may request further information and/or clarification. This review period itself could then be a relatively quick process, perhaps just a few months, but EDAP's best estimate for a response from the FDA is Q4 of 2013.
In 1989, three prestigious European research groups united in their efforts and initiated a project to develop an efficient and non-surgical treatment for localized prostate cancer.
After ten years of development Ablatherm® HIFU was approved for treatment in Europe. At present, Ablatherm® HIFU is being used throughout Europe, Russia and other Asian countries. To date, thousands of patients have been treated successfully in many European centers and throughout the world.Research
Ablatherm® HIFU has been extensively used in Europe. One report of 803 patients published in 2010 showed that 85% of the patients had negative prostate biopsies and 83% had PSA levels at seven years indicating that they were disease free.
So far in our experience of patients undergoing Ablatherm® HIFU only 7% of patients have required further treatment for their prostate cancer. In those developing a recurrence, they remain candidates for surgery, radiation or hormone therapy.
Ablatherm® HIFU treatment has a similar success rate to radical prostatectomy but has the major advantage of using non-invasive technology with fewer side effects.
Download HIFU Brochure (pdf)
Ablatherm HIFU is an outpatient procedure that does not involve surgery and takes approximately two hours.