Medifocus Completes Prolieve Post-Approval Study

FDA has completed its review of the agency-required Medifocus post-approval study of its Prolieve Thermodilation system. The company says the study involved 225 symptomatic benign prostatic hyperplasia (BPH) patients. The 12-year study with five-year follow-up data confirms long-term safety, efficacy, and durability of the treatment with improved lower urinary tract symptoms, urinary flow rate, quality of life, and minimal sexual side effects when compared to an untreated age-matched male population, Medifocus says.

The Prolieve system is described as a “novel focused heat therapy that utilizes a combination of focused heat energy directed at the prostate in combination with a patented, cooled and pressurized dilation balloon to achieve immediate and long-term relief of BPH symptoms with very minimal treatment related side effects after a brief in-office procedure performed under local anesthesia.”