Businesswire08.09.16
NeoTract Inc., a company focused on addressing unmet needs in the field of urology, has 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 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, Texas, 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 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).”
The video below shows the UroLift treatment technique, as administered by a physician:
After four years, over 86 percent 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:
In addition, the publication noted that:
“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 of NeoTract. “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).
The U.S. Food and Drug Administration-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.
NeoTract Inc. develops minimally invasive 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.
Author Claus Roehrborn, M.D., professor and chair of the Department of Urology UT Southwestern Medical Center in Dallas, Texas, 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 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).”
The video below shows the UroLift treatment technique, as administered by a physician:
After four years, over 86 percent 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 percent and 62 percent improved from baseline, respectively;
- An improved quality of life (QoL), with the QoL score improved 52 percent 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 of NeoTract. “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).
The U.S. Food and Drug Administration-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.
NeoTract Inc. develops minimally invasive 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.