MRI Guided Focused Ultrasound System Uses Sound Waves to Ablate Prostate Tissue without Incision

Insightec’s (Haifa, Israel) Exablate Prostate system received FDA 510K clearance in November 2021 for treating prostate tissue with high intensity focused ultrasound. The treatment is performed under MRI guidance for high resolution visualization of the patient’s anatomy for precise targeting and real-time temperature monitoring. The treatment does not require incisions, is performed in a single session, allowing patients to quickly return to normal activity with minimal complications. An Insightec-sponsored clinical trial has demonstrated that Exablate Prostate resulted in minimal damage to adjacent structures, with low rates of impact on potency and continence.

“Exablate Focused Ultrasound has been shown to provide effective control of locally-confined prostate disease in select patients based on 2-year biopsy outcomes,” said Behfar Ehdaie, MD, MS, a urologic surgeon at Memorial Sloan Kettering Cancer Center, and trial PI. “Precision ablation together with MR imaging and thermal feedback may enable men to consider a tissue preserving approach and defer or avoid radical therapy.”

"We are deeply committed to continuing to transform patient care with minimally invasive, innovative surgical procedures. The Exablate Prostate system will help support a better quality of life for people diagnosed and living with prostate disease," commented Maurice R. Ferré MD, Insightec CEO and Chairman of the Board of Directors.

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