August 1, 2023: Francis Medical today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Vanquish minimally invasive water vapor ablation therapy
The Vanquish® Water Vapor Ablation System has been cleared as a tool for the thermal ablation of targeted prostate tissue via a transurethral approach. The FDA has not evaluated the Vanquish System for the treatment of any disease, including prostate cancer, or evaluated the Vanquish System for any long-term prostate cancer treatment outcomes.
Federal law (USA) restricts this device to sale by or on the order of a physician.
Refer to the device User Manual for a list of contraindications, warnings, and cautions.
Training: Do not operate the Vanquish System without completing Francis Medical-provided physician training. Untrained operation of the device may lead to improper use. Improper use can result in patient injury or equipment malfunction.