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

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

4. 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

5. 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.  

6. 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.

7. 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.

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

9. 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

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

11. 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.

12. 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