David Spellberg M.D., FACS HIFU AND CRYOSURGERY David Spellberg M.D., FACS

HIFU with the Sonablate® 500 The Sonablate® 500 is a medical device that uses HIFU to thermally ablate the prostate.

High Intensity Focused Ultrasound What is HIFU? HIFU stands for High Intensity Focused Ultrasound Non-Invasive therapy that focuses sound waves to create heat Similar to light traveling through a magnifying glass to create heat Raises the temperature of the target tissue to almost 195 degrees Fahrenheit (90 degrees Celsius) Destroys the targeted tissues where sound waves cross 2000 W/cm2 Transducer Focal Point

Status of HIFU in the US The Sonablate® 500 is being studied in clinical trials for use in the treatment of prostate cancer in the United States and is not approved for use by the U.S. Food and Drug Administration. HIFU with the Sonablate® 500 is authorized for use for the treatment of prostate cancer in Canada, Argentina and the Dominican Republic. It is also available in the Bahamas and Mexico.  

Brief History of HIFU HIFU research began in the 1950s in Indianapolis, IN. Over the years HIFU has evolved to the applications we have today which include treating various types of cancer and diseases. In 2004, the first International HIFU Centers opened in the Americas.

The Sonablate® HIFU Procedure 1-4 hour outpatient procedure, depending on size of prostate Spinal/epidural anesthesia with light sedative Therapy is delivered through a transrectal probe after patient is numbed from the waist down 1-2 hour recovery at HIFU treatment facility After procedure, most patients resume normal lifestyle within a few days In most cases, HIFU is a one time procedure. It is non-surgical, radiation free and has minimal blood loss.

Recovery & Follow Up Patients have a catheter that is removed 14-21 days after HIFU. Office visit with doctor required for removal. Check PSA at 3, 6, 9 and 12 months then yearly thereafter.

Side Effects & Complications HIFU results from a study done in Japan show low rates of both Impotence (<2%) Incontinence (<0.6%) Minimal Complications Discomfort associated with catheter Tissue passing Most are temporary and mild

MRI Pre and Post HIFU MRI Image of prostate 2 weeks MRI Image of prostate Pre-HIFU

USHIFU Results & Data Physicians have treated more than 3000 patients in Mexico, the Dominican Republic and Canada. According to a Japanese study, the disease free rate after 6 years is 97% for low risk patients (PSA < 10; Gleason < 6) Another small study from the UK showed that 92% of men had Nadir PSA of 0.2 ng/ml or lower after 3 months.

Cryosurgery Treats localized prostate cancer by freezing and destroying prostate cancer cells13 A probe filled with liquid nitrogen is guided through a skin incision into the cancer tissue using transrectal ultrasound (TRUS), which allows the physician to monitor the freezing process13 31