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# New Labeling OK’d for Prolieve Transurethral ThermoDilatation
- URL: https://www.fdaweb.com/new-labeling-okd-for-prolieve-transurethral-thermodilatation/
- Published: 2018-12-03T12:00:00.000Z
- Updated: 2026-09-15T00:48:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142948

FDA has approved a Medifocus PMA supplement for new labeling for its Prolieve Transurethral ThermoDilatation Therapy based on the results from the company’s benign prostatic hyperplasia (BPH) post-approval study, which showed durable and lasting clinical benefits for at least five years of follow-up. The study involved 225 men with BPH treated using the Prolieve system, a combination therapy simultaneously using focused microwave heating together with pressurized balloon dilatation therapy. The 45-minute, in-office, outpatient procedure is performed under local anesthesia and patients do not require a post treatment foley catheter about 90% of the time in contrast to the other treatment options, the company says. Additionally, it says most patients experience significant and immediate relief of their BPH symptoms.