Insightec noted the first patient to be treated outside of a clinical trial with its Insightec Exablate Prostate system occurred recently at Stanford Health Care.
The Exablate Prostate system received 510(k) clearance from the U.S. Food and Drug Administration in November 2021. The system uses sound waves to destroy targeted tissue in the prostate, with treatment performed in a single session under MRI guidance for high-resolution visualization of a patient's anatomy. The treatment is incisionless and typically allows patients to quickly return to normal activity, according to the company.
Stanford Health Care participated in clinical trials for the Exablate Prostate system and reported minimal damage to adjacent structures and low rates of impact on potency and continence, Insightec added.
