EDAP-TMS FRANCE TMS 239320 Focal One

The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The Focal One system consists of the following main sub-assemblies: Focal One Control Module, Dynamic Focal Probe, and consumable Focalpak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.Imported diagnostic data can be fused with the real time ultrasound image in order to facilitate the targeting of the ablation volume.