Insightec receives FDA IDE approval for prostate cancer comparative study using high-intensity focused ultrasound technology

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insightec featuredInsightec, a global healthcare company dedicated to using acoustic energy to transform patient care, announced that it has received US Food and Drug Administration (FDA) approval for an investigational device exemption (IDE) for a clinical comparative study of the Exablate Prostate system used to treat diseased prostate tissue. This study will evaluate the safety and efficacy of focal treatment using high-intensity focused ultrasound when compared to active surveillance in men living with prostate cancer.

The Insightec Exablate Prostate system uses soundwaves to ablate targeted tissue in the prostate. The treatment is performed under magnetic resonance imaging (MRI) guidance for high-resolution visualisation of the patient’s anatomy for precise targeting and real-time temperature monitoring. The single-session treatment does not require incisions and allows patients to return to normal activities quickly, with minimal complications.

“We are excited to continue this important research that can impact on the standard of care for prostate cancer treatment,” said Behfar Ehdaie, a urologic surgeon at Memorial Sloan Kettering Cancer Center (New York, USA), and principal investigator for the study. “Exablate Focused Ultrasound has been shown to provide an accurate, safe, and effective option to engage the prostate gland directly in selected patients based on two-year biopsy outcomes.”

A previous Insightec-sponsored clinical trial led by Memorial Sloan Kettering Cancer Center for the Exablate Prostate system reported minimal damage to adjacent structures and low rates of impact on potency and continence, supporting function and quality of life for patients. The new comparative study builds on the evidence of this clinical trial and aims to further enhance prostate treatment options and improve clinical outcomes.

The Insightec Exablate Prostate system received 510(k) FDA clearance in November 2021, making way for the system to be offered to patients in a commercial facility and for further clinical studies. In January 2022, the system was used to treat prostate disease in its first US commercial patient.

Results from the new study will define the role of focal therapy to delay and avoid radical therapy for men with prostate cancer and support expanded clinical adoption of the technology and increased access for patients through insurance reimbursement.


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