Insightec announced today that it received FDA 510(k) clearance for its Exablate Prostate system for treating prostate tissue.
Haifa, Israel-based Insightec designed its Exablate Prostate system to use high-intensity focused ultrasound to ablate targeted tissue in the prostate. Health providers perform the procedure under magnetic resonance imaging (MRI) guidance for high-resolution visualization of the patient’s anatomy for precise targeting and real-time temperature monitoring.
According to a news release, the treatment does not require incisions and is performed in a single session, allowing patients to quickly return to normal activity with minimal complications.
Clinical trial results demonstrated that the Exablate Prostate system resulted in minimal damage to adjacent structures with low rates of impact on potency and continence, Insightec said.
“Insightec remains focused on achieving strategic milestones and expanding into indications beyond neurosurgery such as approval for prostate tissue ablation,” Insightec CEO & Chairman Dr. Maurice R. Ferré said in the release. “Incisionless surgery is transforming patient care with a surgical option that is considerably less invasive.”