FDA IDE Approval for Ultrasound Prostate Ablation Device

FDA has granted Profound Medical Investigational Device Exemption approval to begin a pivotal clinical trial to evaluate the efficacy of the TULSA-PRO System in patients with localized prostate cancer. The device is designed to combine real-time Magnetic Resonance Imaging with “transurethral robotically-driven ultrasound and closed-loop thermal feedback control providing a highly precise prostate treatment tailored to patient-specific anatomy,” according to the company. Data from the trial are expected to support a future 510(k) submission, it says.

One of the research sites is at Vanderbilt University Medical Center. “As an institution, we recognize the potential of MR-guided therapeutic ultrasound ablation and are investing a lot of resources in this direction,” researchers are quoted in a release as saying. “We expect prostate ultrasound ablation to be an important part of our therapeutic armamentarium in the future.