Insightec Announces FDA Clearance for Exablate Prostate
Thursday, December 02, 2021
Insightec, a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy, announced today that the Exablate Prostate system received FDA 510K clearance for treating prostate tissue with high intensity Focused Ultrasound.
The Exablate Prostate system uses sound waves to ablate, or destroy, targeted tissue in the prostate. The treatment is performed under Magnetic Resonance Imaging (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.
“Exablate Focused Ultrasound has been shown to provide effective control of locally-confined prostate cancer 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.”
The Insightec-sponsored clinical trial demonstrated that Exablate Prostate resulted in minimal damage to adjacent structures, with low rates of impact on potency and continence.
“The results in our clinical trial patients undergoing focal therapy using Exablate have been truly impressive. I’m very excited to bring this new technology to more men with localized prostate cancer,” said Dr. Geoffrey Sonn, Assistant Professor of Urology at Stanford University.
“Insightec remains focused on achieving strategic milestones and expanding into indications beyond Neurosurgery such as approval for prostate tissue ablation,” said Maurice R. Ferré MD, Insightec’s CEO and Chairman of the Board. “Incisionless surgery is transforming patient care with a surgical option that is considerably less invasive.”