Vanquish Water Vapor System used in first commercial prostate ablation

Francis Medical recently announced completion of the first commercial procedure using the Vanquish Water Vapor System for prostate tissue ablation in a patient with intermediate-risk, localized prostate cancer.¹

The procedure was performed at Pinnacle Surgery Center in Austin, Texas, by Eric Giesler, MD, of Urology Austin.

According to Francis Medical, the Vanquish System is a “transurethral, ultrasound and electromagnetically guided, thermal water vapor device used to convectively ablate targeted prostate tissue.” The device was granted 510(k) clearance by the FDA in December 2025 based on results from the prospective VAPOR 2 trial (NCT05683691).²

"As a VAPOR 2 clinical study site, it is gratifying to see this innovative technology receive FDA clearance," noted Giesler in a news release from Francis Medical.¹ "This allows me to offer patients an option that is designed to deliver reliable ablation while potentially reducing the risk of [adverse] effects. Our first commercial procedure with the Vanquish System underscores Urology Austin's commitment to bringing rigorously evaluated, advanced technologies to our community.”

Initial 12-month data from the VAPOR 2 trial demonstrated the safety and efficacy of the Vanquish Water Vapor System in the first 110 patients in the trial who had intermediate-risk, localized prostate cancer. In total, the trial intends to enroll 235 patients across 26 clinical trial sites in the US.

At 6 months, 91% of eligible patients (n = 110) showed elimination of targeted MRI visible, biopsy confirmed intermediate-risk disease (≥GGG2) 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.”

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 that receiving the treatment was a wise decision.

"Today marks a milestone that took years of innovation, collaboration, and clinical partnerships to achieve," concluded Christopher M. Dixon, MD, Francis Medical chief medical officer, in the news release from the company.¹ "I am proud of the Vanquish System and the potential this technology has to deliver clinical outcomes without negatively impacting patients' quality of life, as is commonly seen with traditional treatment options."

The VAPOR 2 trial is ongoing. According to Francis Medical, longer-term outcomes from the study are intended to support a premarket approval submission for an expanded indication of the Vanquish System for clinically localized prostate cancer.

REFERENCES

1. Francis Medical announces first commercial procedure with the Vanquish® Water Vapor System for prostate tissue ablation. News release. Francis Medical, Inc. February 3, 2026. Accessed February 3, 2026. https://www.prnewswire.com/news-releases/francis-medical-announces-first-commercial-procedure-with-the-vanquish-water-vapor-system-for-prostate-tissue-ablation-302677604.html

2. Francis Medical receives FDA 510(k) clearance for use of the Vanquish® Water Vapor System for prostate tissue ablation. News release. Francis Medical. December 2, 2025. Accessed February 3, 2026. https://www.francismedical.com/francis-medical-receives-fda-510k-clearance-for-use-of-the-vanquish-water-vapor-system-for-prostate-tissue-ablation/