12-Month Results from Study of NeoTract’s UroLift® System for BPH in Men with an Obstructive Median Lobe Published in Prostate Cancer and Prostatic Diseases
WAYNE, Pa.--(BUSINESS WIRE)--Dec 14, 2018--NeoTract, a wholly owned subsidiary of Teleflex Incorporated (NYSE:TFX) focused on addressing unmet needs in the field of urology, today announced the publication of 12-month data from the multi-center prospective MedLift™ Study of the UroLift ® System treatment for Benign Prostatic Hyperplasia (BPH) in patients with an obstructive median lobe. Results were published in Prostate Cancer and Prostatic Diseases, a Nature Publishing Group journal.
The MedLift Study provided clinical evidence to support the safety and efficacy of the UroLift System treatment for BPH, or an enlarged prostate, involving a median lobe obstruction. Median lobe obstructions are present in a subset of men with BPH. Results from this study led to the recent U.S. Food and Drug Administration (FDA) clearance of an expanded indication for the UroLift System, making patients who have an obstructive median lobe eligible to receive the UroLift System treatment for BPH symptoms.
“New options are needed for men with an obstructive median lobe, as treatment can be particularly challenging. This condition can cause a higher risk of urinary retention and result in a high failure rate of medical therapy for lower urinary tract symptoms due to BPH,” said Dr. Gregg Eure from Urology of Virginia in Virginia Beach, Virginia, a lead investigator and co-author of the MedLift Study paper. “The outcomes of this study, which showed significant and rapid improvements in BPH symptoms and quality of life measures, demonstrate the safety and effectiveness of the UroLift System for these patients.”
Data published from the MedLift Study show that patients who were treated for obstructive median lobe with the UroLift System experienced significant improvements in IPSS (International Prostate Symptom Score), Qmax (peak flow rate), and QoL (quality of life) scores:Mean IPSS improved from baseline by at least 13.5 points (p<0.0001). Quality of life and BPH Impact Index scores were improved (>60 and >70 percent, respectively at 3, 6, and 12 months, p<0.0001). Mean Qmax improvement ranged from 90-129 percent (p<0.0001). At 1 month, 80 percent of men (95% CI 66- 89 percent) reported being ‘much’ or ‘very much better;’ and 89 percent (95% CI 76-95 percent) would recommend the procedure. Bother due to ejaculatory function improved rapidly and remained modestly improved at 1 year (p=0.001). No patient reported de novo sustained ejaculatory or erectile dysfunction.
“The MedLift Study provides additional evidence of the UroLift System’s utility for the treatment of a broad range of men with BPH, allowing more patients to benefit from this minimally invasive technology,” said Dave Amerson, president of the Teleflex Interventional Urology business unit. “The data from this study, among the many supportive findings from a number of clinical and real-world studies of the UroLift System, have helped the UroLift System become a standard of care treatment for patients with BPH. Treatment with the UroLift System remains the only BPH procedure shown to alleviate BPH symptoms without causing new onset, sustained erectile or ejaculatory dysfunction.”
The outcomes from this study were consistent with those found in the five-year pivotal L.I.F.T study of the UroLift System for patients with lateral lobe enlargement, demonstrating rapid, significant, and sustained improvements in symptoms and quality of life for patients who have an enlarged median lobe, while also preserving their sexual function with no instances of new, sustained erectile or ejaculatory function. No differences were observed in symptom relief based on the size of median lobe protrusion, and the majority of patients required only one additional UroLift permanent implant in the median lobe to achieve lasting relief from BPH symptoms.
About the UroLift® System
The FDA-cleared UroLift System is a proven, 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. Over 80,000 men have been treated with the UroLift System in the U.S. 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 Prostatic Urethral Lift procedure is recommended for the treatment of BPH in both the American Urological Association and European Association of Urology clinical guidelines. The UroLift System is available in the U.S., Europe, Australia, Canada, Mexico and South Korea. Learn more at www.UroLift.com.
About NeoTract | Teleflex Interventional Urology
A wholly owned subsidiary of Teleflex Incorporated, the Interventional Urology Business Unit is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our 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.NeoTract.com.
About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit www.teleflex.com.
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch®, UroLift® and Weck® – trusted brands united by a common sense of purpose.
Gregg Eure is a paid consultant to NeoTract | Teleflex Interventional Urology.
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PUB: 12/14/2018 06:45 AM/DISC: 12/14/2018 06:45 AM