BERLIN, GERMANY (Press Release) - EAU 2007 - Two Thousand One (2001),the year of the first long-term clinical results ever published on HIFU treatment for localised prostate cancer. Long follow-up available with Ablatherm@ HIFU device only.

A worldwide technological innovation, 'Ablatherm@ is a medical device for the treatment of prostate cancer. Approved in May1999 after 10 years of tests and studies, Ablatherm@ is now used in around 120 centres worldwide and will soon have enabled nearly 12 000 patients to be treated.

The worldwide technological innovation called Ablatherm@ HIFU is a robotized medical device for the non-invasive treatment of localized prostate cancer. It is the fruit of a team work between the urology department of the Edouard Herriot Hospital in Lyons (France) and INSERM, the French National Institute for Medical Research (see the stories of Dr A. Gelet P 5 and Dr JY. Chapelon). It has been developed on an industrial scale by EDAP, which specialises in cutting-edge technology medical devices and which is now the world leader in the area of therapeutic ultrasound and more particularly in HIFU technology (High Intensity Focalised Ultrasound).

Ablatherm@ is now as effective as reference treatments. The treatment is based on the use of High Intensity Focused Ultrasound: the beams converge extremely precisely on the targeted area, causing a very brief rise in temperature (from 80 to 90°C). The targeted tissue is then instantly and effectively destroyed, while the surrounding tissue is preserved, showing a radical difference in relation to treatment using ionising rays, which destroy a great deal more of the surrounding tissue.

The study carried out between 1995 and 2000 on 402 patients in 6 European hospitals shows a disappearance of cancerous tissue in over 87% of patients treated first of all. The follow-up of patients treated at the H6pital Edouard Herriot (Lyons) has enabled the establishment of a cure rate, with no re-occurrence within 5 years, of 85% in patients who had a favourable prognosis before treatment.

And this provides hope men whose cancer has come back after radiotherapy Ablathermy also provides hope for those men whose cancer has come back after radiotherapy, for whom Ablatherm@ appears as the most effective recovery treatment with local inspection of the tumour observed in 84% of patients.

Unlike radiotherapy, cure therapy and surgery, Ablatherm@ may also be repeated if necessary and may be associated with other treatments.

Today, treatment by Ablatherm@ is offered as priority to patients who are not suitable for radical surgery, either because of their age or because of associated illnesses which make surgery too much of a risk.

The clinical results obtained with Ablatherm@ HIFU over the last ten years and its adoption by the medical community clearly position EDAP as the world leader in the treatment of localized prostate cancer by HIFU. Over 120 hospitals and clinics are now routinely using this advanced technology which confirms the positive results that have been obtained thus far. The number of sites using Ablatherm@ HIFU is increasing at a quickening pace and illustrates the huge interest in Ablatherm@ HIFU technology. At the same time patient awareness is growing fast and enquiries about Ablatherm@ HIFU treatment are growing more and more frequent because it shows comparable effectiveness to other existing treatment methods with a lower incidence of side effects resulting in a superior quality of life. The www,hifuplanet. com website which provides extensive information to patients about Ablatherm@ HIFU, receives thousands of visits weekly and hundreds of questions are answered every month by Ablatherm@ HIFU specialists.

The Ablatherm@ device & second generation innovations:
The Ablatherm@ principle is based on the delivery of energy by an ultrasound transducer integrated into an endorectal probe: the ultrasound waves are spread through the rectal wall and are focused on the prostate. At the transducer focal point the acoustic absorption of the tissues creates an immediate and intense rise in temperature above 80°C. The maintenance of the emission of ultrasounds for a few seconds enables the heated area to be extended to the prostate capsule and therefore create irreversible coagulation necrosis of the tissue in this volume. The complete treatment of the prostate is obtained by moving the endorectal probe step by step repeating the shooting sequence (between 250 to 800 times depending on the volume to be processed). The prostate limit is determined by the surgeon first of all by an ultrasound scan on the monitor screen, which defines the area to be treated.

Ablatherm@ Generation 2
Available since April 2005, the current version of the device offers integrated imagining which enables the prostate tissue to be seen and treated at the same time, while the initial device required these tasks to be carried out one after the other. To do this, the two ultrasound and therapeutic systems have been brought together inside the same probe. "This new configuration of the probe in no way changes the effectiveness in relation to the previous one as the principle is exactly the same," noted Dr Rafael Varona, medical director at EDAP, "but it enables the surgeon to monitor the treatment directly and in real time",

Updating Ablatherm@ 1 to Ablatherm@ 2
Currently the two versions exist in equal numbers in hospitals, but the trend is of course towards the development of generation 2 equipment everywhere. ''To do this, we are taking back machines one by one and our teams are updating them" specifies Fabrice Romano, marketing director at EDAP.

The transformation involves changing:
• The probe, by replacing the model fitted with separate treatment and imaging transducers with a probe in which the two types of transducer are integrated into the same probe
• The electronic piloting system (i.e. the computer)
• The inspection software.

The update of the first generation Ablatherm device park should be carried out within the next 1 to 2 years.

EDAPTMS
EDAP TMS S.A. develops, produces and markets a range of high technology equipment intended for non-invasive therapy, essential designed for the treatment of urological problems, Its subsidiary EDAP S,A. currently develops and markets equipment intended for the non-invasive treatment of localised prostate cancer by high energy focused ultrasound (HIFU), Moreover, the group produces and markets via its TMS S,A. subsidiary equipment intended to destory kidney stones (lithotritry) via shock waves,

The clinical results which have been obtained with Ablatherm@ over the last ten years and its adoption by the medical community clearly position EDAP as the world leader in the treatment of prostate cancer by HIFU. Over one hundred hospitals and clinics now use this advanced technology and confirm the positive results which have been obtained up to now. Ablatherm@ is now the only device which offers therapy via HIFU for localised prostate cancer and is supported by the results of multicentre studies which show its effectiveness in relation to traditional therapies

Ablatherm@ HIFU is now the only device with such significant scientific references in terms of published clinical results which offers therapy via HIFU for localised prostate cancer and is backed up by the results of multi-centre studies which demonstrate its effectiveness in relation to traditional therapies. At the end of 2006, the total number of treatments by Ablatherm@ HIFU was approximately 11,000 in 120 sites versus 6,600 treatments in 2004 in 63 sites.

"Proof that the technology can be exported and is beginning to be used routinely in several countries is that several foreign doctors - British, Spanish, German - have come to Lyons to be trained by ablathermy's pioneers themselves'~ Fabrice Romano was delighted to declare.

2005 marked the launch of Ablatherm@-HIFU in new markets such as Canada, Australia and Great Britain. In addition, EDAP TMS is anticipating future growth essentially generated by the HIFU division, given the interest in prostate cancer treatment by ablathermy which just keeps on growing.

EAU 2007 Conference Coverage on UroToday.com

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