NeoTract reports positive five-year results from UroLift trial for BPH
US-based firm NeoTract has reported positive five-year results from the LIFT IDE trial of UroLift System to treat symptomatic benign prostatic hyperplasia (BPH) patients.
UroLift System is designed to deliver permanent implants through a minimally invasive transurethral outpatient procedure to alleviate the obstruction of the prostate and open the urethra.
The results from the prospective, randomised, sham-controlled, blinded LIFT trial showed that the system is highly tolerable, minimally invasive and mitigates symptoms with sustained effect.
The trial assessed the safety and efficacy of the system in 430 patients aged 50 years and above at 19 clinical sites in the US, Canada, and Australia.
NeoTract president and CEO Dave Amerson said: “We’re thrilled about the positive momentum for this treatment, with growing clinical adoption around the world and tens of thousands of men with lives that have been changed for the better.
“Payors are recognising the value of the UroLift System as well, as we estimate more than 70% of American men with BPH now covered.”
During the five-year study period, subjects were evaluated for symptom response using IPSS, quality of life through IPSS QOL and BPHII, peak flow rate measured by Qmax, sexual function using IIEF and MSHQ-EjD, and adverse events.
The system is reported to be tolerable under local anaesthesia in an office setting, has delivered swift recovery and relief without the requirement of a post-operative catheter, and has improved symptoms, flow and quality of life.
The UroLift System is currently available in the US, Europe, Australia, Canada, Mexico, and South Korea.