FDA grants 510(k) clearance to Vanquish Water Vapor System for intermediate-risk prostate cancer

On December 2, 2025, the FDA granted 510(k) clearance to the Vanquish Water Vapor System for prostate tissue ablation in patients with intermediate-risk prostate cancer, Francis Medical announced in a news release.¹

“Patients with intermediate risk prostate cancer currently weigh oncologic risk with quality of life in their treatment decision making,” said Dr. Samir Taneja, senior vice president of Northwell Health, in the news release.¹ “It is exciting to see FDA clearance of this promising technology, with the early results showing that water vapor may provide an efficacious option for prostate cancer management with lower risk of side effects as compared to conventional therapies.”

The approval is supported by 12-month data from the prospective VAPOR 2 trial (NCT05683691), in which treatment with the Vanquish Water Vapor System demonstrated efficacy and safety in the first 110 patients with 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 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.”

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.

“The patient satisfaction data further supports the exciting potential for Vanquish in the management of prostate cancer,” said Arvin George, MD, director of Prostate Cancer Programs at the Brady Urological Institute of Johns Hopkins University, and a VAPOR 2 co-principal investigator.¹ “Most patients experienced no pain, quickly resumed daily activities, and indicated high rates of satisfaction with their procedure and decision at 12 months.”

The trial remains ongoing. Longer term data from the trial are intended to support a pre-market approval submission for an expanded indication in clinically localized prostate cancer.

“FDA clearance allows us to offer an alternative to patients with localized prostate cancer that better balances oncologic and quality of life risks. Early VAPOR 2 study results validate the potential for water vapor technology to manage prostate cancer while addressing the long-term side effects typically experienced with traditional treatments,” concluded Mike Kujak, president and CEO of Francis Medical, in the news release.¹ “We will continue to follow the VAPOR 2 patients as we strive to fulfill our mission to be a first line therapy in patients with prostate cancer that is tough on cancer and gentle on patients.”

REFERENCE

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 2, 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/