FDA sanctions NeoTract’s indications for Urolift System

Wholly owned subsidiary of Teleflex, NeoTract emphasizing to address and resolve needs in the field of urology declared that the U.S Food and Drug Administration has sanctioned new indications for the UroLift System for the treatment of enlarged prostate, or benign prostatic hyperplasia (BPH). These expanded indications mean that patients who have an obstructive median lobe and those as young as 45 are now eligible to receive treatment with the UroLift System for their BPH symptoms.

Dave Amerson, president, NeoTract | Teleflex Interventional Urology claimed “The clinical data we have amassed on the UroLift System, including the five-year data from the L.I.F.T. IDE study, has solidified the product’s position as an important standard-of-care treatment for men with BPH and is further bolstered by these expanded indications. We are diligently training current UroLift users on how to treat obstructive median lobes with the UroLift System so they continue to see optimal patient outcomes.”

The treatment incorporating the UroLift System has demonstrated that it can get men off BPH medications and allow them to avoid major surgery, while preserving sexual function. Results of the five-year L.I.F.T. study demonstrate that the UroLift System treatment provides a highly tolerable, minimally invasive procedural experience, rapid reduction of symptoms after the procedure while preserving sexual function, and sustained improvements in QoL (Quality of Life) score, IPSS (International Prostate Symptom Score), and Qmax (peak urinary flow rate). In addition, the retreatment rate was just 2-3% per year, which compares well to the 1-2% expected rate for the gold standard TURP.