PLEASANTON, Calif.--(BUSINESS WIRE)--NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced that the first patients have been enrolled in the MedLift™ U.S. IDE trial.
The MedLift IDE trial is a new study that will be conducted across eight U.S. sites. The study is designed to demonstrate safety and effectiveness of the UroLift® System for the treatment of patients with benign prostatic hyperplasia (BPH) who have an obstructive median lobe, which is currently contraindicated in the United States. Obstructive median lobes are present in approximately 5% to 10% of BPH patients who would otherwise be eligible for treatment with the UroLift System.
“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,” said Euclid deSouza, M.D., principal investigator at Adult & Pediatric Urology, PC in Omaha, Neb. "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.”
“Most BPH men have some form of a median lobe and UroLift is an effective treatment option, but in a small subset this lobe can become obstructive,” said Ronald Tutrone, M.D., principal investigator at Chesapeake Urology in Towson, Md. “UroLift would be valuable to patients with obstructive median lobes since their treatment options are limited. Patients I see with obstructive median lobes typically require more aggressive treatment which can come with more complications," he added.
“This new clinical study will continue to advance our understanding of the benefits of the UroLift System,” said Dave Amerson, president and CEO, NeoTract. “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.”
Men who are interested in enrolling in the MedLift trial may obtain more information by visiting www.clinicaltrials.gov (NCT02625545) or by calling (650) 739-5570.
About BPH
There are more than 500 million men globally who suffer from BPH, a condition in which the prostate enlarges as men get older. Chronic lower urinary tract symptoms (LUTS) associated with BPH can cause loss of productivity and sleep, depression and decreased quality of life. Medication is often the first line therapy but relief can be inadequate and temporary. Side-effects can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative has been surgery that cuts or heats prostate tissue to open the blocked urethra. Although effective, patients typically only achieve symptom relief after a difficult period of irritative voiding symptoms and wearing a urinary catheter. Even the 'gold standard' surgery, TURP (Transurethral Resection of the Prostate), can 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, Mexico, South Korea and Canada. Learn more at www.UroLift.com.
About NeoTract
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.
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