Large Real-World Study Backs up UroLift ’s Effectiveness

Teleflex Inc. received favorable results for a multi-center study reaffirming the safety and effectiveness of its UroLift System. The Wayne, PA-based company said the results were published in the Journal of Endourology. The multi-center, retrospective study examined the results of 1,413 consecutive patients who received the UroLift System for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The trial took place over the course of two years across 14 sites in North America and Australia. Data published from the study show that patients from multiple subgroups treated with the UroLift System experienced improvements in IPSS (International Prostate Symptom Score) and QoL (Quality of Life) score: Consistent with the pervious L.I.F.T. study, symptoms improved significantly from baseline at all follow up time points through two years, and most perioperative adverse events were mild to moderate, resolving by four weeks In a cohort-matched comparison to L.I.F.T. study patients with moderate-severe symptoms (IPSS ≥13), symptom improvement was similar at all time points Of the 165 patients in retention at baseline, 83% became catheter-free by one-month post-procedure and 87% were catheter-free by the end of the study; IPSS scores were similar to non-retention patients In the 73 patients with prior prostate cancer treatment, mean IPSS improved at all time points with no significant difference in adverse events of interest compared to...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news