Disclaimer

IMPORTANT INFORMATION:
The Sonablate® 500 is not approved for use in the U.S. The Sonablate® 500 remains investigational in the U.S. and is being studied for the treatment of prostate cancer in clinical trialsin the U.S. FDA has made no decision as to the safety or efficacy of the Sonablate® 500 for the treatment of prostate cancer. Currently, the device is approved for the treatment of prostate cancer in Canada and the Dominican Republic, authorized in Argentina, and available in the Bahamas and Mexico.
If the Sonablate® 500 is approved by the FDA for use in the U.S., there is no assurance that instructions for use or the specifications of the device will be the same as the device and treatment approved or authorized in other countries outside of the U.S.