FDA Approved

  • Two devices cleared for HIFU by  FDA approval in October 2015: The Ablatherm and Sonablate systems

  • FDA has determined that the HIFU DEVICE IS indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue, can be classified in class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.”

  • EDAP is a French Company with a market cap of $100 million. HIFU Technology  was jointly developed in the early 1990s by Inserm (French Institute of Medical Research), HCL (Lyon University Hospitals) and EDAP TMS, and has been used routinely for more than 20 years throughout the world

  • Sonacare is a private company that has done 10 years of FDA trial work for HIFU to get Sonablate Device approved

  • According to Jonathan Jarrow, MD, FDA Clinical reviewer Ablatherm, the 510k intended use: HIFU devices indicated for high intensity focused ultrasound (HIFU) ablation of prostate tissue, “A good analogy is the scalpel. A Scalpel is a tool to cut tissue but is not approved to treat specific diseases (e.g., prostate cancer or aortic aneurysm)”

Ablatherm Robotic HIFU System

Over 270 clinical sites

Over 65,000 treatments

Robotic probe system is incorporated into table to provide stability, ease of use, and transportability

Robotic Movement of HIFU Probe allows millimeter precision of tissue treatment

Patented Ablasonic Fluid Infusion

Keeps Rectum Cool and Avoids Injury

  • Effectively ablates prostate cancer tissue

  • Highly precise with millimeter accuracy and  lesion demarcation

  • Radiation free

  • Robotically controlled and reproducible

  • Noninvasive.

  • Ablatherm HIFU Ablates cancer cells effectively and does not seed metastasis.*

  • Three dimensional robotic motion

    • 3 translations and 2 rotations

    • Image recognition software detects rectal wall, fine tunes the probe position

  • Integrated ultrasound transducers avoid compromise

    • 7.5 MHz imaging

    • 3 MHz ablation

  • Patented AblasonicTM fluid for consistent ultrasound transmission

  • 25cc/hour ablation speed