FDA grants expanded indication for the use of the UroLift System to treat larger prostates, between 80cc and 100cc.-Teleflex Incorporated

Teleflex Incorporated announced that the 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). BPH, also known as enlarged prostate, is non-cancerous enlargement of the prostate that occurs as men age. The condition 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. The collection of 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 received 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. “We have learned from the Real-World study and other clinical studies that the UroLift System is the only minimally invasive treatment option that delivers rapid relief and recovery in days not months,” said Thomas J. Mueller , M.D., New Jersey Urology. “I am pleased that this indication will enable even more men to benefit from this groundbreaking technology.” Comment: The Prostatic Urethral Lift procedure using the UroLift System is recommended for the treatment of BPH in both the American Urological Association and European Association of Urology clinical guidelines.