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Localized prostate cancer treatment by Focused Ultrasound in more than 20 European Hospitals

EDAP, the global leader in minimally invasive medical devices based on the innovative High Intensity Focused Ultrasound technology (HIFU), announces the availability of the Ablatherm® in six European countries as of March 2003. The Ablatherm® is a computer-driven HIFU device for the treatment of localized prostate cancer that allows physicians to treat the prostate non-invasively without damaging intervening and surrounding tissue. The numerous advantages of the Ablatherm® treatment include precise local treatment in one session, repeatable treatment if necessary, a low complication rate and a short period of hospitalization.

From March onwards, more than 20 hospitals in six European countries will be treating localized prostate cancer with the Ablatherm®. At the beginning of 2002, 9 hospitals were equipped with an Ablatherm®. The availability of the Ablatherm® HIFU device in hospitals in Belgium, France, Germany, Italy, Spain and Switzerland testifies to the growing success of the minimally invasive treatment. Since the first treatment in 1993, more than 3200 treatments have been performed to date. More than a third of the treatments were conducted in 2002. The number of treatments per year increased by 65 per cent from 2000 to 2001, and by 59 per cent from 2001 to 2002.

With more than eight years follow-up, HIFU with Ablatherm® has emerged as the most promising among minimally invasive treatment options today. A multicentric study was carried out between 1995 and 2000, including 652 patients in 6 sites, with most patients treated with Ablatherm® as a first choice therapy. Negative biopsies were observed in 87,2 % of the patients and at least 50 % of the patients presented a nadir PSA at 0.1 or less after a complete treatment.

The Ablatherm® treatment is performed under general or spinal anesthesia with the patient in right lateral position. After insertion of the endorectal probe, the physician visualizes the prostate with the bi-plan ultrasound imaging probe and defines the area to be treated. The computer automatically calculates the optimum distribution of lesions. The physician then switches the probe to firing mode. The probe emits a beam of high intensity convergent ultrasound. In the point where the ultrasound is focused, the sudden and intense absorption of the ultrasound creates an elevation of the temperature (from 85 to 100 °) The transducer automatically moves and fires each pre-defined lesion until the entire volume has been treated.

Since the Ablatherm® received the CE mark in 2000, it has been available for sale worldwide, except in the US and in Japan where specific regulatory procedures are in progress.