Jan. 07, 2020: Teleflex announced that the U.S. Food and Drug Administration (FDA) has granted the company an expanded indication for the use of its UroLift® System to treat larger prostates, between 80cc and100cc.
This minimally invasive, in-office treatment provides rapid relief and recovery from the symptoms of benign prostatic hyperplasia (BPH), is non-cancerous enlargement of the prostate that occurs as men age. The situation affects over 40 million men in the United States alone.
More than 40% of men in their 50s have BPH and over 80% of men in their 70s have BPH. The symptoms of BPH can include frequent urination and can cause loss of productivity, depression and decreased quality of life. If left untreated, the condition can worsen over time and cause permanent bladder damage.
Data presented to the FDA demonstrates that the UroLift System treatment is safe and effective in men with prostate sizes between 80cc and 100cc, with outcomes similar to the L.I.F.T. randomized controlled trial. Further, there are no discernable differences in reported adverse events, indicating a comparable safety profile.
There is also a strong and growing body of clinical evidence supporting the safe, effective use of the UroLift System, including a large retrospective real-world study which highlights the results of 1,413 patients who inward the UroLift System treatment across 14 sites in North America and Australia.
Results were consistent with those seen in previous clinical studies of the UroLift System treatment, and included patient subgroups—such as those in retention, with large prostates and comorbidities such as diabetes and prostate cancer—not commonly seen in clinical trials. https://fda.einnews.com/pr_news/506556989/teleflex-announces-fda-clearance-for-expanded-indication-of-the-urolift-system-for-treatment-of-larger-prostates-up-to-100cc