Francis Medical has concluded the first commercial procedures using its Vanquish water vapour ablation system for prostate tissue ablation in Arizona, US.
The system was used on patients with localised prostate cancer by Dr Rahul Mehan at the East Valley Urology Center of Arizona.
These operations were performed outside formal clinical trials and mark the initial use of the Vanquish system in standard clinical practice within the state.
The device employs an ultrasound, transurethral and electromagnetically guided thermotherapy process to ablate prostate tissue with high-energy sterile water vapour.
The US Food and Drug Administration (FDA) granted 510(k) clearance to the Vanquish system in November 2025. This approval was based on positive follow-up data from the first 110 patients enrolled in Francis Medical’s ongoing VAPOR II pivotal trial.
At six months in the VAPOR II study, 91% of eligible patients demonstrated elimination of targeted magnetic resonance imaging (MRI) visible, biopsy-confirmed intermediate-risk disease after a single procedure.
The therapy was well-tolerated, and there were no device-related serious adverse events.
Additionally, low rates of urinary incontinence and erectile dysfunction were reported. Patient feedback also indicated minimal or no pain after treatment.
VAPOR II data at 12 months showed that 93% of patients reported they were satisfied or extremely satisfied, and 94% believed receiving the Vanquish treatment was a wise decision. Patients will be monitored for longer-term results supporting a pre-market approval submission for expanded indications.
The FDA has not assessed the system for disease treatment or long-term outcomes.
Francis Medical president and CEO Mike Kujak said: “These first commercial procedures in Arizona represent an important milestone in our controlled US launch strategy.
"Transitioning from clinical study experience to real-world urological practice underscores the level of dedication, preparation, and operational rigour that has defined our early launch phase.
“We are optimistic that the technology will deliver upon its early clinical promise and provide a minimally invasive alternative to men concerned by their prostate health.”
In December 2025, the FDA cleared the device to treat intermediate-risk prostate cancer.
