June 9, 2020: Francis Medical, Inc. announces the enrollment of their first patient in the company’s VAPOR 1 clinical study, an early feasibility study evaluating the safety and efficacy of the company’s minimally invasive water vapor ablation therapy for the treatment of prostate cancer
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.