NeoTract said Monday it enrolled the 1st patient in its MedLift U.S. investigational device exemption trial of its UroLift system for treating patients with benign prostatic hyperplasia.
The new study from Pleasanton, Calif.-based NeoTract will be conducted across 8 sites in the U.S. and will examine the safety and efficacy of the UroLift system for treating patients with BPH who have an obstructive median lobe, which the company says is currently contraindicated in the U.S.
“Unlike other BPH procedures, the UroLift System directly opens the urethra without cutting, heating, or removing prostate tissue. In this way patients experience very rapid and durable relief. This treatment option has been very successful for many of my BPH patients who are unhappy with medical therapy and concerned about the lengthy recovery and side effects common with other procedures,” princpial investigator Dr. Euclid deSouza said in a press release.
“This new clinical study will continue to advance our understanding of the benefits of the UroLift System. We are thrilled that the UroLift System has improved quality of life for thousands, and we look forward to bringing this innovative therapy to even more patients,” CEO Dave Amerson said in a prepared statement.
Last September, NeoTract touted a new analysis from the U.K.’s National Institute for Health and Care Excellence that reported a (UK £286) $443 savings per patient per day when using its UroLift system to treat enlarged prostates, compared to the most common surgical intervention.
The NICE reported other benefits of the system, including preservation of sexual function, improved quality of life and reduced recovery time with the treatment, compared to the standard treatment, Neotract said.