Teleflex Announces Results of Four Studies Accepted at ICS 2020 Annual Meeting

Teleflex

WAYNE, PA — Teleflex Incorporated (NYSE: TFX) recently announced the results of four studies that were accepted at the ICS 2020 Annual Meeting – Online reinforcing the safety and efficacy of the UroLift® System for the treatment of benign prostatic hyperplasia (BPH).

“BPH commonly causes bothersome urinary symptoms that can affect quality of life. With over 40% of men over the age 50 living with BPH,1 the robust data presented at ICS highlight the advantages of the UroLift System as a preferred treatment option for many men suffering needlessly from BPH symptoms,” said Dave Amerson, president of the Teleflex Interventional Urology business unit.

“Prostatic Urethral Lift, or PUL, using the UroLift System is an effective and durable treatment for BPH, and a frequent recommendation to my patients who experience difficulties voiding as a direct symptom of BPH,” said Thomas Mueller+, M.D., New Jersey Urology. “The enlarged prostate presses on and can block the urethra, causing bothersome urinary symptoms. The results of PUL studies presented at ICS indicate that it is a safe and effective option for men with BPH.”

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Dr. Mueller’s oral presentation, Results from the Large Real-World Study of the Prostatic Urethral Lift (PUL) Demonstrate Consistent Safety and Effectiveness for BPH Patients, was a recipient of the Best In Category Prize for Male Lower Urinary Tract Symptoms (LUTS). The clinical research was designed to expand upon the growing body of evidence of the effectiveness, safety and symptomatic relief of PUL for BPH in a real-world retrospective study. This was the largest real-world investigation of PUL, with male participants averaging 70 years old. Results confirmed that PUL can be offered to a wide patient population in a real-world setting while maintaining the symptomatic improvement and safety profile observed in the pivotal LIFT trial.

UroLift System treatment efficacy was further confirmed in the real-world setting with Parallel Outcomes of the Prostatic Urethral Lift from Two Distinct Multicenter Real-World Studies, presented by Karl-Dietrich Sievert+, M.D., Klinikum Lippe, Detmold Germany. Two published real-world studies, the German Multicenter Retrospective Study and the Large Real-World Retrospective Study, of PUL were compared to assess UroLift System performance. In non-retention subjects, symptom response, quality of life (QoL), and Qmax outcomes were largely consistent between the two real-world studies. Catheter-independence rates of retention subjects were also equivalent, with 86% independence in the German Multicenter Retrospective Study and 87% independence in the Real-World Retrospective Study.

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Prostatic Urethral Lift (PUL) Can Reduce Voiding Bladder Pressure Demonstrated by Penile Cuff Test was presented by Brian Mazzarella+, M.D., of Midtown Urology. This was the first study to evaluate real-world penile cuff testing (PCT) outcomes in men with BPH before and after PUL. Outcomes in International Prostate Symptom Score (IPSS) (p=0.03), QoL (p=0.2) and flow improvement (p=0.1) improved significantly at three months. Using PCT, researchers demonstrated that penile cuff pressure measurements improved by 16% three months after PUL (p=0.07), and 44% of subjects moved out of the obstructed flow category.

The Mechanism of Action of the Uniquely Designed Prostatic Urethral Lift Implant was authored by Daniel Rukstalis+, M.D., Prisma USC Division of Urology. This study evaluated the short-term and long-term mechanisms of action of PUL using the UroLift System implant. Twenty-four canines who underwent PUL were evaluated for histopathology. Resected prostate tissue from human subjects was also analyzed to provide further insight into the previously seen symptomatic improvements in humans treated with PUL. The results of the study show that the UroLift System immediately causes localized compression, and sustained pressure by implants results in subsequent tissue remodeling and scarring which contributes to durability of symptom relief.

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+Dr. Thomas Mueller, Dr. Karl-Dietrich Sievert, Dr. Brian Mazzarella and Dr. Daniel Rukstalis are paid consultants of NeoTract | Teleflex Interventional Urology

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