We understand from media reports that the French medical device company EDAP TMS has submitted documentation to the U.S. Food & Drug Administration (FDA) for pre-market approval of their Ablatherm technology for treatment of low-risk, localized prostate cancer with high-intensity, focused ultrasound (HIFU).
Apparently EDAP TMS has stated (see this newsfeed on the MedicalPhysicsWeb site) that their submission is backed by data from the company’s Phase II/III U.S.-based ENLIGHT study. As of this morning, however, there is no media release on the EDAP TMS corporate web site.
The ENLIGHT trial supposedly enrolled more than 400 patients with localized disease between 2006 and 2010 and that these patients were followed through July 2012. In August 2012, EDAP TMS issued a media release stating that the company had completed the trial follow-up and data collection phase.
To date, The “New” Prostate Cancer InfoLink has seen no data reporting the results of this U.S. trial. Data from a European trial that enrolled patients at six European sites between 1995 and 1999 were reported by Thüroff et al. as long ago as 2003.
We should also note that if EDAP TMS is successful in gaining approval to market the Ablatherm technology for treatment of localized prostate cancer, it is possible that their competitor (HIFU International) will bne able to gain approval for the competing Sonablate techology through a so-called 501(k) application, without the need to conduct any further clinical trials.
At present, no form of treatment using HIFU has been approved in the United States for the treatment of any stage or grade of prostate cancer. There is no clear data about how long it may take the FDA to review the data submission referred to above.