With Focal One, urology surgeons can establish precise contours around the diseased tissue and ablate an even smaller portion of the prostate. This lessens the damage to healthy tissue, and minimises side effects of incontinence and impotence for patients. Using Focal One, surgeons can customise the HIFU procedure for each patient and each clinical condition.
“Focal One is a great step forward in using this new and important ultrasound technology for prostate tissue ablation,” said Dr. Brian Miles, Urologist, Professor of Urology, Houston Methodist Hospital – Weill Cornell Medical College.
“Focal One’s ability to merge MRI images, ultrasound images and biopsy data in order to precisely outline and treat just the diseased tissue area of the prostate is truly remarkable.”
“We are thrilled that this innovative technology will now be available to patients and physicians in the United States,” said Marc Oczachowski, Chief Executive Officer of EDAP.
“The FDA’s clearance of Focal One validates not only the power of our technology but also the years of hard work and dedication by our clinical trial investigators and EDAP’s outstanding employees. Focal One’s real-time imaging and 3D robotic features allow for greater precision, leading to improved targeting and treatment planning, and we are excited to be able to expand access to Focal One to the most important healthcare market in the world.”
