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EDAP accelerates HIFU study enrollment

EDAP TMS : 04 June, 2007  (New Product)
EDAP TMS is accelerating its clinical trial study enrollment with the addition of the McMaster University Hospital near Toronto, Ontario.
William L Orovan, MD, FRCSC, FACS, Professor and chair Department of Surgery McMaster University, Ontario, Canada has been treating Ablatherm patients from North America at a private centre since 2005.

'Ablatherm-HIFU is by far the best HIFU technology available with excellent cancer control', stated Dr Orovan.

'It has proven to be the superior HIFU device from the perspectives of precision, imaging capacity and safety'.

'The technique is simple, highly effective and clearly offers tremendous advantages'.

'In our experience over several hundred treatments, we are extremely pleased with the outcomes, which match the clinical data already widely reported in leading journals'.

'Our patients have been very satisfied with Ablatherm therapy, and most are able to resume normal activity within 24 hours of treatment since Ablatherm is less invasive with fewer side-effects'.

'Ablatherm offers top safety protocols active throughout the robotic treatment so the device stops application instantly if any parameter becomes a concern, as compared to other devices requiring manual intervention, which may not provide as rapid of a response for patient safety', Dr Orovan continued.

'Considering that Ablatherm-HIFU is proven repeatable and has no therapeutic impasse, this gives patients the most complete ability to preserve quality of life and all medical options in treating localised prostate cancer'.

'This is another step in our stated plans to accelerate our US trials', said Marc Oczachowski, CEO of EDAP.

'During the recent AUA Congress EDAP was approached by numerous centres, including the top US institutions in cancer care, about joining our study based on the strong clinical evidence already documented from the approved use of Ablatherm-HIFU outside the US where it shows more than 10 years of clear success on more than 12,000 treatments'.

'We will meet those requests in the coming months'.

'This will help EDAP fully enroll the study with centres of unmatched prestige in the USA'.

'We are also excited to now include international centres already using Ablatherm to create a positive treatment experience for patients demanding better options'.

The Ablatherm-HIFU Phases II/III clinical study is currently enrolling men diagnosed with clinical stage T1a, b or c or T2a localised prostate cancer.

HIFU is a noninvasive therapy using highly focused Ultrasound energy to ablate the prostate tissue.

Ablatherm-HIFU is proven effective comparable to other standard nonsurgical treatments of localised prostate cancer, but often offers fewer side effects.
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