Arvin George, MD, reacts to FDA clearance of Vanquish Water Vapor System

In an interview with Urology Times®, Arvin K. George, MD, offers his thoughts on the recent FDA clearance of the Vanquish Water Vapor System for prostate tissue ablation in patients with intermediate-risk prostate cancer.

“This was giving us commercial approval to be able to offer it to patients as a standard of care procedure, rather than an experimental procedure,” George explained. “It also gives us some validation that we have a safe procedure that has minimal impacts, [which] we've been able to demonstrate in terms of quality of life for patients.”

George is a urologic oncologist at the director of the prostate cancer program at Johns Hopkins Medicine in Baltimore, Maryland.

The 510(k) clearance was supported by 12-month data from the VAPOR 2 trial (NCT05683691), which were presented at the 2025 Society of Urology Oncology Annual Meeting in Phoenix, Arizona. Overall, data supported the safety and efficacy of the treatment in this patient population.²

At 6 months, 91% of eligible patients (n = 110) showed no targeted MRI visible intermediate-risk disease following a single Vanquish procedure. According to the company, “the Vanquish System demonstrated the ability to effectively treat cancerous lesions in all prostate locations, addressing a significant limitation of existing ablative options.”¹

Treatment was also well-tolerated, with no device-related serious adverse events and low rates of urinary incontinence and erectile dysfunction. Patient-reported outcomes were also promising, with patients generally indicating minimal to no pain following the procedure. At 12 months following treatment, 93% of patients indicated that they were satisfied or extremely satisfied, and 94% said that they believed receiving the treatment was a wise decision.

REFERENCES

1. Francis Medical receives FDA 510(k) clearance for use of the Vanquish® Water Vapor System for prostate tissue ablation in patients with intermediate risk prostate cancer. News release. Francis Medical. December 2, 2025. Accessed December 3, 2025. https://www.francismedical.com/francis-medical-receives-fda-510k-clearance-for-use-of-the-vanquish-water-vapor-system-for-prostate-tissue-ablation-in-patients-with-intermediate-risk-prostate-cancer/

2. George A. Thermal water therapy for the management of prostate cancer: the VAPOR 2 study. Interim analysis. Presented at: Society of Urologic Oncology Annual Meeting; December 2-5, 2025; Phoenix, Arizona. Abstract 260. https://suo-abstracts.secure-platform.com/a/gallery/rounds/24/details/4899