Search Results

The Focal One® is indicated for transrectal high-intensity focused ultrasound (HIFU) ablation of prostate tissue.

The Focal One® consists of the Focal One® module with a software control system, an endorectal dynamic focusing probe, a leg support, and a disposable set (FocalPak) including miscellaneous single use disposables and a coupling liquid pouch.

The Focal One® module consists of a motorized and manual endorectal dynamic focusing probe positioning unit, a RF amplifier to power the transducer, a computer to control device operation, a cooling system to cool Ablasonic (coupling liquid) and built-in safety features. It also allows the user to control the treatment while providing different user interfaces: two dual touch-screens, mouse, keyboard and printer. The Focal One® energy is delivered via an endorectal dynamic focusing probe, which includes an imaging system. The high-energy ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating heat and causing the ablation of tissue within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The endorectal dynamic focusing probe is attached to a support, enabling movements in the longitudinal, transverse, vertical and angular directions, and in rotation. A coupling liquid pouch (Ablasonic®) included in the FocalPak disposable kit, attached to a stand, maintained at a controlled temperature flows continuously (via a peristaltic pump) into the balloon to preserve the rectal wall from heating associated with the treatment. The module is mounted on four multidirectional wheels allowing an easy positioning of the device in the treatment room.

N/A

Ask a specific question about this device