EXABLATE PROSTATE

Exablate® Prostate delivers nearly 1000 ultrasound waves to precisely heat and ablate Prostate tissue with no surgical incisions or radiation. Treatment is guided by MR imaging for patient-specific planning, real-time temperature monitoring as well as immediate confirmation of treatment outcome.

The clinical team will use best in class MRI to visualize the prostate throughout the treatment. The Exablate system utilizes specialized software to create a personalized plan to deliver energy effectively to target from a transrectal approach. The clinical team monitors the treatment in real-time using thermometry data to optimize the outcome and then uses a contrast image at the end of the treatment to confirm the delivery.

Regulatory Approvals
Click here to view the regulatory approvals of Insightec products by country.

Important Safety Information

You should have a detailed conversation with your physician regarding complications, also known as adverse events, that you may experience.

Potential Risks associated with Exablate Prostate

In an Insightec-sponsored clinical trial, the majority of AEs reported were either mild (86.5%) or moderate (13%). There was one AE categorized as Severe for a UTI event, which resolved in less than a week. At 12 months, the most common recorded adverse events included erectile dysfunction (16%) and urinary incontinence (7%). The remaining unresolved AEs at 24 months were less than 1% and included ejaculation disorder, urinary frequency, hematospermia, urinary hesitancy, urinary urgency, prostate cyst, and urethra stricture. The number in parenthesis is the percentage of subjects experiencing the event based on a 101 subject study.

 

Potential risks related to the procedure include pain, bruising, or infection in the area of the IV catheter; soreness/discomfort, blood clot, deep vein thrombosis (DVT) or pulmonary embolism due to lying stationary during the procedure; and risks arising from anesthesia, MRI contrast agent, and urinary catheter used during the procedure.

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