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The approval is supported by several studies highlighting the efficacy of Rezūm Water Vapor Therapy in patients with larger prostates.
The FDA has granted 510(k) clearance to a label expansion for the Rezūm System, raising the maximum prostate volume that can be treated with the device from 80 cm3 to 150 cm3 for patients with benign prostatic hyperplasia (BPH).1,2
The device was previously approved in March 2019.
The device was previously approved in March 20193 for patients with BPH with prostate volumes ranging from 30 cm3 to 80 cm3.
“The recent FDA-cleared indication expansion has increased the maximum prostate volume that can be treated with Rezūm Water Vapor Therapy from 80 grams to 150 grams," said Ron Morton, MD, chief medical officer, Urology, Boston Scientific. "Existing real-world and clinical trial data for Rezūm Therapy demonstrated safe and effective treatment of BPH in men with prostate volumes over 80 grams, with significant improvements in functional and quality of life outcomes. The indication expansion underscores Boston Scientific’s commitment to providing comprehensive options to treat men with symptomatic BPH."
Morton added, "The indication expansion for Rezūm Therapy is clinically important in the US as it provides physicians and patients another treatment option that doesn’t require general anesthesia when treating large prostate glands (defined as 80-150 grams by the American Urological Association). Rezūm Therapy continues to offer its intended benefits: it is minimally invasive, suitable for ambulatory settings and has no negative impact to sexual function."
The approval is supported by several studies highlighting the efficacy of Rezūm Water Vapor Therapy in patients with larger prostates. The first, published in Urology,4 was a systemic review and meta-analysis suggesting that treatment with Rezūm provided a statistically significant and clinically meaningful improvement in short-term relief of lower urinary tract symptoms (LUTS) while demonstrating a low rate of adverse events (AEs) in men with prostate volumes of at least 80 cm3.
In total, the analysis included 15 studies (11 of which were retrospective studies) that included 471 patients with prostate volumes of at least 80 cm3. The median follow-up was 6 months (range, 3 to 17).
Overall, treatment with Rezūm led to statistically significant improvements in International Prostate Symptom Score (IPSS; mean change, -11.0; 95% CI, -12.2 to -9.7; P < .001), IPSS-QOL (mean change, -2.9; 95% CI, -3.5 to -2.4; P < .001), Qmax (mean change, 6.5 mL/s; 95% CI, 4.8 to 8.2 mL/s; P < .001), and post-void residual (mean change, -101 mL; 95% CI, -145 to -57; P < .001). There was no significant change in International Index of Erectile Function-Erectile Function (IIEF-EF; mean change: 0.3; 95% CI: -1.1, 1.6; P = .71).
Serious AEs were reported in less than 0.1% of patients (95% CI, 0.0% to 0.4%). Further, 1.2% of patients (95% CI, 0.0% to 3.5%) required surgical retreatment.
The FDA also reviewed data from a manufacturer-sponsored prospective, nonrandomized, single-arm study5 and compared these data to results from the pivotal trial of the Rezūm System.6
“The clinical evidence showed overall comparable results between patients with prostate volumes [greater than] 80cm3 and [less than or equal to] 80 cm3,” the agency noted.1 “Use of the proposed device in the expanded patient population does not result in any new concerns of safety or effectiveness.”
In total, the manufacturer-sponsored study included 47 patients with prostate volumes ranging from 80.8 cm3 to 148.1 cm3. Overall, 83% of patients demonstrated a response to treatment at 6-month follow-up. The average improvement in IPSS was 11.9 [plus or minus] 7.5 points at 6 months.
The study also met its primary safety end point, with no instances of device-related composite safety events.
According to the authors, these findings were consistent with those seen from the pivotal trial of Rezūm in prostate glands of up to 80 cm3. In total, the pivotal study included 197 patients who were randomly assigned to receive Rezūm (n = 136) or to the control arm (n = 61). Of the 61 patients in the control arm, 53 crossed over to receive Rezūm at the 3-month time point.
Five-year data from the pivotal trial showed that treatment with Rezūm reduced IPSS by 48% and BPH Impact Index by 48%. Further, patients who received Rezūm showed a 45% increase in quality of life and a 44% increase in maximum flow rate.
The retreatment rate at 5 years was 4.4%. No patients experienced device- or procedure-related sexual dysfunction or sustained de novo erectile dysfunction.
Results were similar among those in the crossover group.
REFERENCES
1. Section 510(k) premarket notification for Rezum System. FDA. June 11, 2025. Accessed June 20, 2025. https://bostonscientific.showpad.com/share/fhLW6RP6GHlhhVecgQsXX
2. 510(k) premarket notification database. FDA. Accessed June 20, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250584
3. Section 510(k) premarket notification for Rezūm System. FDA. March 25, 2019. Accessed June 20, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190093.pdf
4. McVary KT, Miller LE, Bhattacharyya S, et al. Water vapor thermal therapy in men with prostate volume ≥80 cm3: a systematic review and meta-analysis. Urology. 2024:184:244-250. doi:10.1016/j.urology.2023.10.036
5. Woo H, Levin R, Cantrill C, et al. Prospective trial of water vapor thermal therapy for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia in subjects with a large prostate: 6- and 12-month outcomes. Eur Urol Open Sci. 2023 Nov 8:58:64-72. doi:10.1016/j.euros.2023.10.006
6. McVary KT, Gittelman MC, Goldberg KA, et al. Final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2021;206(3):715-724. doi:10.1097/JU.0000000000001778.
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