PLEASANTON, Calif. – NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced the peer-reviewed publication of four-year follow-up data from the pivotal, randomized L.I.F.T. IDE study, which evaluated the safety and effectiveness of the company’s novel UroLift® System in patients with symptomatic benign prostatic hyperplasia (BPH), in Urologic Clinics of North America.
Author Claus Roehrborn, M.D., professor and chair of the Department of Urology UT Southwestern Medical Center in Dallas, was co-principal investigator for the L.I.F.T. clinical program.
“The pivotal L.I.F.T. randomized study confirms that the rapid and significant symptom improvement from treatment with the UroLift System is sustained for at least four years, with durable improved quality of life and preservation of sexual function,” said Dr. Roehrborn. “These clinical outcomes, in combination with UroLift’s procedural benefits, make it a compelling treatment option for a significant population of men with voiding symptoms due to benign prostatic hyperplasia (enlarged prostate gland).”
After four years, over 86% of originally enrolled patients were free from seeking additional procedural treatment for BPH. In addition, the four-year L.I.F.T. study analysis demonstrated that UroLift system treatment provided:
- Rapid reduction of symptoms after the procedure while preserving sexual function;
- Sustained effect, with IPSS (International Prostate Symptom Score) and Qmax (peak urinary flow rate) remaining 41% and 62% improved from baseline, respectively;
- An improved quality of life (QoL), with the QoL score improved 52% over four years
In addition, the publication noted that:
- The UroLift System can be performed in the office with local anesthesia.
- Return to normalcy is rapid, typically without a catheter.
- Future treatment options for patients are preserved.
“The publication of this long-term clinical data is an exciting milestone for NeoTract, on the heels of a number of key positive reimbursement coverage decisions,” said Dave Amerson, president and CEO, NeoTract, Inc. “We are committed to helping men return to normal urinary function, preserve sexual vitality and to providing a great alternative to BPH medications with this safe and effective treatment option – the only BPH procedure that does not require cutting, heating or removal of the prostate tissue.”
Symptoms of BPH often include sleepless nights and urinary problems, and can cause loss of productivity, depression and decreased quality of life. Medication is often the first-line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of medication treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative is surgery that cuts, heats or removes prostate tissue to open the blocked urethra. While current surgical options can be very effective in relieving symptoms, they can also leave patients with permanent side effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm).
About the UroLift System
The FDA-cleared UroLift System is a novel, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function. Patients also experienced a significant improvement in quality of life. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. The UroLift System is available in the U.S., Europe, Australia and Canada. Learn more at www.UroLift.com.
NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. The company’s initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function. Learn more at www.UroLift.com or www.NeoTract.com.
For NeoTract, Inc.: