NeoTract, Inc., presented new and favorable clinical data from two randomized studies of its UroLift system in treating the symptoms of benign prostate hyperplasia (BPH). The presentations were made at the recent American Urological Association (AUA) 2016 Annual Meeting in San Diego, California.
Included in the presentations were data from a four-year follow-up to the pivotal, randomized L.I.F.T. IDE study, which evaluated UroLift’s safety and efficacy in patients with symptomatic BPH, and two-year data from the BPH-6 study, which compared the system with the surgical standard, transurethral resection of the prostate (TURP).
UroLift is a U.S. Food and Drug Administration (FDA)-cleared and minimally invasive device for the treatment of lower urinary tract symptoms (LUTS) due to BPH. UroLift’s permanent implants, delivered through an outpatient transurethral procedure, are designed to relieve prostate obstruction and open the urethra without cutting, heating, or removing prostate tissue.
“The clinical data presented at this year’s AUA conference show that treatment with the UroLift system offered men suffering from BPH a well-tolerated minimally invasive experience that provided uniquely rapid relief and a durable, sustained effect,” Dave Amerson, NeoTract’s president and chief executive officer, said in a press release. “We are proud to offer this safe and effective treatment option that can allow men to stop taking BPH medications and be treated with a simple procedure that does not carry the risk of sexual side effects common with other treatment options.”
Claus Roehrborn, MD, professor and chair of the Department of Urology at UT Southwestern Medical Center in Dallas, presented data on the LIFT IDE study. “While prior data have shown that this treatment option offers rapid relief with low morbidity, the four-year L.I.F.T. study data demonstrate solid durability for a less invasive treatment option,” Dr. Roehrborn, who was co-principal investigator of the clinical program, said. “After four years, over 86% of patients were free from seeking additional procedural treatment for BPH.”
Jens Sønksen, MD, president of the Danish Association of Urology, presented data from the BPH-6 study. “While TURP is the most common treatment for symptoms caused by an enlarged prostate, the side effects can be significant and may cause men to postpone or refuse treatment altogether,” Dr. Sønksen said. “The results of this study provided an overall assessment of the ability of UroLift to improve symptoms without compromising important aspects of health, such as sexual function. We were also delighted to see that UroLift demonstrated superior quality of recovery. These characteristics are of great importance to patients when deciding how to address their symptoms.”