NxThera achieves FDA clearance for Rezum, an in-office treatment for BPH that uses controlled doses of thermal energy stored in water vapor to reduce prostate gland tissue causing urinary tract symptoms.
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.