Title: Pivotal trial of MRI-guided transurethral ultrasound ablation (TULSA) of localized prostate cancer: 4-year follow-up
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Profound Medical is committed to research, innovation, improving procedure efficiency and saving lives. We are dedicated to changing the standard of care through quality clinical evidence, working in close partnership with clinicians, physicians, hospitals, and professional associations.
Ram A. Pathak, MD
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In the United States, TULSA-PRO has 510(k) regulatory clearance and is indicated for the ablation of prostate tissue, on the basis of clinical trials in men with localized prostate cancer where whole-gland ablation of benign and malignant prostate tissue demonstrated significant PSA reduction, prostate volume reduction, and follow-up biopsies that were negative for residual prostate cancer. As with other ablation devices, surgical robots, and radiotherapy machines, TULSA-PRO is a tool for the removal or destruction of prostate tissue; the effectiveness of TULSA-PRO or other devices in treating prostate cancer has not been established.
CAUTION: Products shown may not be approved for sale in all jurisdictions. Rx only device.
Contact us at [email protected] for more information regarding the regulatory status of the device.
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