Rezum System

The Rezūm System is a vapor ablation device that treats benign prostatic hyperplasia (BPH) by using radiofrequency energy to generate water vapor, which is injected into the prostate to reduce tissue volume and relieve urinary symptoms. It is indicated for men aged 50 and older with prostate volumes between 30 and 150 cubic centimeters, including those with central zone or median lobe hyperplasia.

The proposed Rezūm System has identical technological characteristics to the predicate device with no changes to any device features. The only modification is to the Indications for Use, expanding the prostate volume upper limit from ≤80 cm³ to ≤150 cm³, which does not create a new intended use since both versions are designed to relieve BPH symptoms.

Not stated in this summary.

The device is substantially equivalent because the physical device and principle of operation remain unchanged—both the subject and predicate systems use the same vapor ablation mechanism to treat BPH. Clinical evidence from a systematic review and meta-analysis, plus manufacturer-sponsored studies, demonstrates that patients with prostate volumes >80 cm³ and ≤150 cm³ achieve similar safety and efficacy outcomes with comparable adverse event rates and no negative sexual function impact, supporting the expanded indication without introducing new safety or effectiveness concerns.