FDA Clears Francis Medical's Vanquish Water Vapor System for Intermediate-Risk Prostate Cancer Treatment
Key Insights
The FDA granted 510(k) clearance to Francis Medical (search)'s Vanquish Water Vapor System (search) for prostate tissue ablation in patients with intermediate-risk prostate cancer on December 2, 2025.
Clinical data from the VAPOR 2 trial showed 91% of patients had no targeted MRI visible intermediate-risk disease at 6 months following a single procedure.
The treatment demonstrated low rates of urinary incontinence and erectile dysfunction, with 93% of patients reporting satisfaction at 12 months post-procedure.
The FDA granted 510(k) clearance to Francis Medical (search)'s Vanquish Water Vapor System (search) for prostate tissue ablation in patients with intermediate-risk prostate cancer on December 2, 2025, marking a significant milestone for minimally invasive prostate cancer treatment. The approval enables commercial launch of this breakthrough technology that aims to balance oncologic efficacy with quality of life preservation.
Clinical Trial Results Drive FDA Approval
The FDA clearance was supported by 12-month data from the prospective VAPOR 2 trial (NCT05683691), which demonstrated both efficacy and safety in the first 110 patients with intermediate-risk, localized prostate cancer. The multicenter, single-arm study plans to enroll 235 patients across 26 clinical trial sites in the United States.
At 6 months, 91% of eligible patients showed no targeted MRI visible intermediate-risk disease following a single Vanquish procedure. According to Francis Medical (search), the system demonstrated the ability to effectively treat cancerous lesions in all prostate locations, addressing a significant limitation of existing ablative options.
Superior Safety Profile and Patient Experience
The treatment showed a favorable safety profile with no device-related serious adverse events and low rates of urinary incontinence and erectile dysfunction—two common complications associated with traditional prostate cancer treatments such as surgery or radiation. Patient-reported outcomes were particularly encouraging, with patients indicating minimal to no pain following the procedure.
Patient satisfaction data reinforced the clinical benefits. At 12 months following treatment, 93% of patients indicated they were satisfied or extremely satisfied, and 94% said 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 Dr. Arvin George, director of Prostate Cancer Programs at the Brady Urological Institute of Johns Hopkins University and a VAPOR 2 co-principal investigator. "Most patients experienced no pain, quickly resumed daily activities, and indicated high rates of satisfaction with their procedure and decision at 12 months."
Technology and Treatment Approach
The Vanquish System is a transurethral, ultrasound and electromagnetically guided thermal water vapor device that convectively ablates cancerous prostate tissue. The technology uses the energy stored in sterile water vapor to transfer thermal energy to cancerous tissue, causing cell death while potentially minimizing damage to surrounding structures by respecting the prostate's natural boundaries.
The procedure is performed on an outpatient basis, offering a less invasive alternative to conventional treatments. Initial treatments in the VAPOR 2 study were completed in February 2025, and patients will continue to be followed to gather longer-term outcomes to support a premarket approval (PMA) submission for an expanded indication for the management of clinically localized prostate cancer.
Addressing Unmet Medical Need
Prostate cancer represents a significant healthcare challenge, with the American Cancer Society estimating that one in eight American men will be diagnosed with the disease. Current treatments often come with complications that significantly impact quality of life.
"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 and a VAPOR 2 co-principal investigator. "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."
Commercial Launch and Future Plans
The FDA clearance enables Francis Medical (search) to begin commercial launch of the Vanquish System. The company will continue following VAPOR 2 patients to support their mission of becoming a first-line therapy for prostate cancer patients.
"FDA clearance allows us to offer an alternative to patients with localized prostate cancer that better balances oncologic and quality of life risks," said Mike Kujak, president and CEO of Francis Medical (search). "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."