FDA extends indication for UroLift System a treatment for benign prostatic hyperplasia.- NeoTract/Teleflex.

NeoTract, a wholly owned subsidiary of Teleflex Incorporated focused on addressing unmet needs in the field of urology, announced that the FDA has cleared 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.

Previously, the UroLift System was contraindicated in patients with an obstructive median lobe and only cleared for use in men 50 years of age or older. The MedLift study provided clinical evidence to support the safe and effective treatment of obstructive median lobes and to remove the contraindication. The treatment using 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.