October 13, 2015 r. HIFU technology (High Intensity Focused Ultrasound) used in the procedure for the ablation of prostate tumor tissue obtained FDA (Food and Drug Administration) approval – the US government agency responsible for the control of medical equipment, medicines and food available on the American market. Allowing HIFU technology for the US medical market is a huge improvement in the availability of minimally invasive treatment of prostate cancer. It is also a new hope for recovery for many patients from the United States. Distribution of HIFU medical robot in the US is expected to begin this month.
So far, HIFU method has been implemented in 49 countries and its effectiveness has been repeatedly confirmed in clinical studies. It is expected that FDA approval for HIFU technology will contribute in implementation of the technology on a global scale in the coming years. In Poland the pioneers of HIFU method are doctors from HIFU Clinic Prostate Cancer Treatment Centre Marek Filipek MD, PhD., and Stefan W. Czarniecki, MD, who since 2011 have performed more than 120 procedures using medical HIFU robot in both Polish and foreign patients.
Achieving the FDA approval for HIFU technology is a breakthrough moment, because a positive opinion regarding the medical equipment issued by the FDA, is recognized in the international medical community as an indicator of the highest quality and definitive confirmation of the absence of negative impact of the device on the health of the patient. It should also be noted that the control of FDA has very strict rules regarding the procedures that must be followed by the manufacturers of medical equipment - this translates directly into the safety and reliability of the products, which are finally admitted to the medical market. The positive decision of FDA regarding HIFU technology heralds a new era in minimally invasive treatment of prostate cancer and forecasts a significant improvement in quality of life of patients after surgical treatment of prostate cancer.
For more information about HIFU method, diagnostics and treatment of prostate cancer please call +48 512 077 461 or write at kontakt@hifu.pl.
