PIVOTAL TRIAL OF MRI-GUIDED TRANSURETHRAL ULTRASOUND ABLATION (TULSA) OF LOCALIZED PROSTATE CANCER: 4-YEAR FOLLOW-UP
Pavlovich et al, The Journal of Urology (2023)
THE FUTURE IS INCISION-FREE
TULSA-PRO® empowers physicians to customize the prostate disease treatment of every patient aiming to preserve urinary and sexual function with an incision-free, MRI-Guided, robotic outpatient procedure1. TULSA-PRO physicians have utilized this technology globally and have documented patient outcomes in over 40 clinical publications. Profound is committed to continually improving the TULSA-PRO technology, procedure time, and patient lives.
What is TULSA-PRO
TULSA-PRO is a game-changing technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The system is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum aiming to preserve the patient’s natural functional abilities 1. TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).
Genius Services
Profound is proud to offer TULSA-PRO users access to Genius Services providing our partners with support and resources at every stage of adoption including a partnership with our Clinical Team, Service Team, Marketing Team, Reimbursement Team, and PRO-Talk Academy. Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives.
TULSA-PRO REIMBURSEMENT
1. Klotz, et al. “MP46-03-Pivotal trial of MRI-guided transurethral ultrasound ablation in men with localized prostate cancer: Three-year follow-up”. The Journal of Urology Suppl (2021)
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CAUTION: TULSA-PRO® is approved for commercial sale in the USA (K191200) & EU (CE 2797[HR1] ) & Canada (103887). Rx only device.
For all other Regulatory jurisdictions, please contact us at info@profoundmedical.com for more information regarding the regulatory status of the device.