The European Association of Urology (EAU) has raised the rating of the UroLift system to the highest possible classification, Level 1A, in its recently updated guidelines for male lower urinary tract symptoms (LUTS).
NeoTract, Inc., the medical urology company that developed UroLift, also presented clinical data resulting from two multinational studies, the four-year durability results of the L.I.F.T. randomized study and two-year results of the BPH6 randomized study, at the recent EAU Conference in Munich.
First-in-line BPH therapy usually includes medication, but such therapy can lead to side effects such as dizziness, headache, and sexual dysfunction. In patients unresponsive to drug therapies or who develop related complications, surgeries that cut or ablate prostate size are the alternative, such as transurethral resection of the prostrate (TURP). Despite high success rates in relieving symptoms, this surgery is also associated with side effects, including bleeding, incontinence, and erectile dysfunction.
The UroLift system is a minimally invasive technology for treating LUTS due to BPH. It consists of permanent implants designed to relieve prostate obstruction and open the urethra without cutting, heating, or removing prostatic tissue. Moreover, the system is implanted in a quick procedure feasible with local anesthesia, with or without sedation. Clinical data on this U.S. Food and Drug Administration-cleared system shows that patients with enlarged prostates receiving the UroLift system have significant improvements in symptom management, urinary flow rate, and quality of life without compromise of sexual function. Most adverse events, mild to moderate in severity, disappeared within two to four weeks after the procedure. The system is available in the U.S., Europe, Australia, Canada and Mexico. Following a positive NICE (National Institute for Health and Care Excellence) review, based on its economic and clinical benefits, UroLift is now being offered by multiple publicly funded NHS hospitals in the U.K.
“We at NeoTract are delighted that the EAU has recognized the high quality of clinical data behind UroLift. This is a watershed moment for the UroLift System, which is becoming more widely available to patients as healthcare systems recognize the clinical benefits to patients and the economic advantages to the health systems of respective countries,” Justin Hall, NeoTract’s EMEA vice president and general manager, said in a press release. “Daily, we see evidence of increasing demand across Europe from patients and their partners for the UroLift System, a less invasive, true day case procedure that can be carried out under local anesthesia showing zero de novo risk of impact on sexual function and rapidly improves quality of life for couples whose lives are severely impacted by BPH.”