Insightec has received an investigational device exemption (IDE) from the U.S Food and Drug Administration (FDA) for a clinical study of its Exablate Prostate system to treat diseased prostate tissue.
The system uses MRI-guided high-intensity focused ultrasound (HIFU) to ablate targeted tissue in the prostate. The system allows for high-resolution visualization of patient anatomy for precise targeting and real-time temperature monitoring, the company said. In addition, treatments are performed in a single session and do not require incisions.
The study will evaluate the safety and efficacy of focal treatment using the device when compared with active surveillance in men living with prostate cancer, Insightec said.
